90 Regulations jobs in Singapore
Regulatory Affairs
Posted today
Job Viewed
Job Description
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
Regulatory Affairs
Posted today
Job Viewed
Job Description
The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
Mentoring
Talent Management
Strategic Planning
Talent Development
Legislation
Regulatory Affairs
Marketing Strategy
Investigation
Customer Care
Surveillance
Advocacy
Team Management
Evidence
Product Development
Manufacturing
Business Requirements
Regulatory Affairs
Posted today
Job Viewed
Job Description
The role will be responsible for achieving corporate objectives and effectively ensuring that agreed strategies are implemented. Accountable for all regional and local regulations for the statutory compliance of all regulatory and QA affairs activities of the Company.
A key requirement will be to balance internal hands-on execution priorities with regional strategic alignment, and at the same time, be able to navigate the current complex policy environment.
Contribute with regulatory skills to the innovation of products and services focusing on improving patient's outcome. The role requires strong understanding of the regional business environment, work in collaboration with regulatory/ Q&R team in the markets, strong interaction with corporate/manufacturing RA teams on Regulatory Affairs matters.
To represent Terumo and participate in industry associations (e.g. APACMed, MTAA, etc.) to create Terumo voice of advocacy.
Key Functions/Responsibilities
Strategic Planning:
• Developing and implementing regional regulatory strategies and processes to support the timely registration of new products, major changes and life cycle management.
• Recommend strategies to the business units on ways to resolve issues related to regulatory premarket activities and promote strong partnerships to drive
implementation and resolution.
• Represent Terumo in local or regional standards committees, industry associations, national competent authorities influencing future regulations and standards and deploy them in the organization
• Proactively identify market opportunities by influencing product registration, prioritizing product registration, mitigate potential regulatory approval risks based
on regulations, standards, country-specific issues or other unique characteristics
• Effectively communication between global, TAP RA to ensure implementation of
all strategic plans.
Operation Efficiency:
• Coordinate with Regulatory Affairs in the manufacturing units and CRAO and
regulatory affairs teams in the countries under the scope to ensure optimal,
efficient and compliant registration and QA reporting.
• Lead and drive RA/QA activities in accordance with local and international
requirements to ensure Terumo products are registered on time or life cycle
management in the markets are in scope of responsibility, and post marketing
surveillance risks are minimised.
• Responsible for Regulatory monitoring and analysis of new or updated local
legislation and for assuring in-time registration in the local market (country).
• Create a regulatory plan and a labelling plan (when needed) to ensure
consistency and guidance to the market introduction projects.
• Improve efficiency of entity RA teams to create a cogent process of
documents/data management / storage and / or document flow which is easy and
efficient for access to relevant stakeholders.
• Work with in-country RA teams to ensure product compliance by executing the
annual regulatory plan and reviewing all relevant compliance evidence.
• Consult with product and solutions teams to ensure timely, effective and efficient
transition to new requirements.
• Management of distributors and ensure compliance on RA&QA matters
• Encourage creation and use of automated / visual dashboards and scorecards
for as many business and function process tracks
Talent Development and Management:
• Act as a mentor and supporter to the in-country regulatory affairs team members.
• Share knowledge and guide and mentor others about regulatory best practices
and registration standards for regulatory approvals and post-market needs.
• Work with HR to actively, plan, develop and assess learning needs of key
Associates, with specific focus on current and future business needs of the
organization
• Build a personal network within the relevant talent community and take personal
accountability in attracting, developing, mentoring, retaining and growing best
regulatory affairs talent in the region
• Provide TAP/RA associates with educational programs about RA knowledge enhancement, Terumo group products, and BU marketing strategy.
• Organise yearly Asia RA meeting for development and planning of RA yearly
strategy plans.
Deliver through a hands-on management style:
• Gemba (visiting field or floor), Gembutsu (seeing actual products in R&D,
production and use), and Genjitsu (facing reality) are fundamental Terumo /
Japanese business traits. it is important for this role to demonstrate this.
• Always remain accessible and practice open management. Support teams in
execution of product requirements and registration.
Champion of Terumo culture:
• Work on establishing a close-knit, collaborative and supportive team within the
region. Understand BUs operations and priorities, work cooperatively with others
across the organization to achieve shared objectives to support business
requirements.
• Be a quality champion by viewing each issue from a "Gemba" perspective in order
to find the optimal solution. Pursue excellence in product quality, from product
supply to customer care.
• Focus efforts on continuous improvement; has a knack for identifying and seizing
opportunities for synergy and integration. Figure out the process necessary to get
things done
Education & Experience:
• Graduate or Post Graduate degree/s. (Medical / biomedical background)
• Working experience in Regulatory Affairs Medical Device (class 1, 2 and 3) is a must
• A minimum of 5 years working experience in Regulatory Affairs in APAC Team management experience.
• Proficient in Japanese and ability to transcribe dossier from Japanese to English
Key Technical/Functional Competencies:
• High level of regulatory concepts and standards
• Knowledge of product development and clinical investigation
• Highly regarded personal work ethics and character
• Talent Management. People skills extraordinaire, people empathy & compassion
• Open, inspiring and high quality communication style.
• Willingness to ask for help
• Relevant in-country & sectoral / sub-sectoral understanding (an exception can be made for a highly talented candidate)
Head of Compliance (Licensing and Regulations)
Posted 1 day ago
Job Viewed
Job Description
Head of Compliance (Licensing and Regulations)
Head of Compliance, Regulatory & Licensing (Digital Assets)
OverviewWe are seeking a highly experienced Head of Compliance to lead regulatory, compliance, and licensing matters for our digital assets business. The successful candidate will serve as the appointed Compliance Officer under the Monetary Authority of Singapore (MAS) regulatory regime and oversee the company’s Major Payment Institution (MPI) license obligations. This is a senior leadership role working closely with the CEO, board, and regulators to ensure full compliance with all applicable laws and regulations.
Key Responsibilities- Act as the Head of Compliance/Director and MLRO , ensuring compliance with MAS requirements under the Payment Services Act (PSA).
- Lead the MPI license application process, renewals, and ongoing regulatory reporting to MAS.
- Develop, implement, and maintain compliance policies, frameworks, and internal controls relating to AML/CFT, KYC, sanctions, transaction monitoring, and suspicious transaction reporting.
- Provide strategic advice on crypto regulatory matters , including stablecoins, digital payment tokens, custody, and fund transfers.
- Liaise with regulators, auditors, and external legal advisors to ensure smooth inspections and audits.
- Train and advise management and staff on compliance and regulatory developments.
- Monitor regulatory changes in Singapore and globally, assessing their impact on business operations.
- Ensure accurate, timely submission of regulatory filings, incident reports, and compliance attestations.
- Collaborate with business units (e.g., trading, custody, payments) to balance compliance requirements with business objectives.
- Serve as a point of contact for AML/CFT matters, regulatory inspections, and compliance-related queries.
- Bachelor’s degree in law, Finance, Accounting, or related discipline; advanced qualifications (e.g., CAMS, ICA) preferred.
- Minimum 6–10 years of compliance experience in financial services, payments, fintech, or crypto-related companies.
- Proven track record with MAS regulations and MPI licensing process under the Payment Services Act.
- Strong expertise in AML/CFT frameworks, regulatory reporting, and internal audit processes.
- Deep understanding of crypto/digital assets regulations, risks, and industry best practices.
- Excellent communication skills to engage with regulators, management, and cross-functional teams.
- Ability to work independently, make strategic compliance decisions, and manage a compliance team.
- Competitive compensation package.
- Opportunity to lead compliance strategy in a fast-growing digital assets company.
- Direct interaction with senior management and regulators.
- Dynamic work environment at the forefront of fintech and blockchain innovation.
EV Regulations Manager (Data & Systems) - spvw
Posted 5 days ago
Job Viewed
Job Description
We are hiring a motivated individual to lead the development and regulation of digital platforms supporting electric vehicle (EV) charging systems in Singapore.
- Contribute to the digital transformation of national sustainability efforts.
- Work on meaningful, large-scale data and platform projects.
- Engage with multiple stakeholders to shape future-ready infrastructure
Responsibilities:
- Lead initiatives to collect, manage, and publish EV charging data such as real-time availability and pricing.
- Manage the development of digital tools for charger planning, data integration, and system monitoring.
- Coordinate with development teams and vendors to ensure successful prototyping, testing, and deployment.
- Plan for post-launch platform maintenance, including vendor transition and operations support.
- Collaborate with external stakeholders on data transmission, platform security, and system integration.
- Ensure robust measures are in place for safeguarding data and maintaining long-term platform sustainability.
Requirements:
- Degree in a data-related or technical discipline (e.g. engineering, data science, IT).
- Strong project coordination and stakeholder management experience.
- Comfortable working in a fast-paced environment across multiple initiatives.
- Meticulous with documentation, system planning, and risk assessment.
- Experience with platform development or IT systems is preferred.
- Knowledge of EV charging communication protocols is a bonus but not required.
- Strong communicator and collaborative team player across technical and non-technical groups.
- Prior involvement in Government project.
By submitting your resume, you consent to the collection, use, and disclosure of your personal information per ScienTec’s Privacy Policy (scientecconsulting.com/privacy-policy).
This authorizes us to:
Contact you about potential opportunities.
Delete personal data not required at this application stage.
All applications will be processed with strict confidence. Only shortlisted candidates will be contacted.
Wong Vi Yin (Vanessa) – R
ScienTec Consulting Pte Ltd – 11C5781
EV Regulations Manager (Data & Systems) - spvw
Posted today
Job Viewed
Job Description
We are hiring a motivated individual to lead the development and regulation of digital platforms supporting electric vehicle (EV) charging systems in Singapore.
- Contribute to the digital transformation of national sustainability efforts.
- Work on meaningful, large-scale data and platform projects.
- Engage with multiple stakeholders to shape future-ready infrastructure
Responsibilities:
- Lead initiatives to collect, manage, and publish EV charging data such as real-time availability and pricing.
- Manage the development of digital tools for charger planning, data integration, and system monitoring.
- Coordinate with development teams and vendors to ensure successful prototyping, testing, and deployment.
- Plan for post-launch platform maintenance, including vendor transition and operations support.
- Collaborate with external stakeholders on data transmission, platform security, and system integration.
- Ensure robust measures are in place for safeguarding data and maintaining long-term platform sustainability.
Requirements:
- Degree in a data-related or technical discipline (e.g. engineering, data science, IT).
- Strong project coordination and stakeholder management experience.
- Comfortable working in a fast-paced environment across multiple initiatives.
- Meticulous with documentation, system planning, and risk assessment.
- Experience with platform development or IT systems is preferred.
- Knowledge of EV charging communication protocols is a bonus but not required.
- Strong communicator and collaborative team player across technical and non-technical groups.
- Prior involvement in Government project.
By submitting your resume, you consent to the collection, use, and disclosure of your personal information per ScienTec’s Privacy Policy (scientecconsulting.com/privacy-policy).
This authorizes us to:
Contact you about potential opportunities.
Delete personal data not required at this application stage.
All applications will be processed with strict confidence. Only shortlisted candidates will be contacted.
Wong Vi Yin (Vanessa) – R
ScienTec Consulting Pte Ltd – 11C5781
Head of Compliance (Licensing and Regulations)
Posted today
Job Viewed
Job Description
Head of Compliance (Licensing and Regulations)
Head of Compliance, Regulatory & Licensing (Digital Assets)
Overview
We are seeking a highly experienced Head of Compliance to lead regulatory, compliance, and licensing matters for our digital assets business. The successful candidate will serve as the appointed Compliance Officer under the Monetary Authority of Singapore (MAS) regulatory regime and oversee the company’s Major Payment Institution (MPI) license obligations. This is a senior leadership role working closely with the CEO, board, and regulators to ensure full compliance with all applicable laws and regulations.
Key Responsibilities
- Act as the Head of Compliance/Director and MLRO , ensuring compliance with MAS requirements under the Payment Services Act (PSA).
- Lead the MPI license application process, renewals, and ongoing regulatory reporting to MAS.
- Develop, implement, and maintain compliance policies, frameworks, and internal controls relating to AML/CFT, KYC, sanctions, transaction monitoring, and suspicious transaction reporting.
- Provide strategic advice on crypto regulatory matters , including stablecoins, digital payment tokens, custody, and fund transfers.
- Liaise with regulators, auditors, and external legal advisors to ensure smooth inspections and audits.
- Train and advise management and staff on compliance and regulatory developments.
- Monitor regulatory changes in Singapore and globally, assessing their impact on business operations.
- Ensure accurate, timely submission of regulatory filings, incident reports, and compliance attestations.
- Collaborate with business units (e.g., trading, custody, payments) to balance compliance requirements with business objectives.
- Serve as a point of contact for AML/CFT matters, regulatory inspections, and compliance-related queries.
Requirements
- Bachelor’s degree in law, Finance, Accounting, or related discipline; advanced qualifications (e.g., CAMS, ICA) preferred.
- Minimum 6–10 years of compliance experience in financial services, payments, fintech, or crypto-related companies.
- Proven track record with MAS regulations and MPI licensing process under the Payment Services Act.
- Strong expertise in AML/CFT frameworks, regulatory reporting, and internal audit processes.
- Deep understanding of crypto/digital assets regulations, risks, and industry best practices.
- Excellent communication skills to engage with regulators, management, and cross-functional teams.
- Ability to work independently, make strategic compliance decisions, and manage a compliance team.
What We Offer
- Competitive compensation package.
- Opportunity to lead compliance strategy in a fast-growing digital assets company.
- Direct interaction with senior management and regulators.
- Dynamic work environment at the forefront of fintech and blockchain innovation.
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Regulatory Affairs, Manager
Posted today
Job Viewed
Job Description
- Salary Range MYR 7,000 - 7,999
- City Bandar Sri Damansara
- Country Malaysia
- Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
- Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
- Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
- Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
- Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
- Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
- Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
- Manage post-market regulatory obligations, including the reporting of device-related incidents and complaints, ensuring all submissions are timely and compliant with applicable requirements.
- Ensure compliance with advertisement and labeling regulations in each marketing territory.
- Oversee and supervise compliance with other regulatory requirements from authorities such as MOH (MY), HSA (SG), NEA (SG), IMDA (MY/SG), DVS (MY/SG), and AVS (MY/SG).
- Plan and lead the implementation of internal RA audits on an annual basis.
- Support external audits conducted by regulatory agencies, principals, and suppliers by providing regulatory input to minimize the risk of non-compliance findings.
- Provide regulatory support during internal audits of subsidiaries and associated companies across Southeast Asia.
- Collaborate with Conformity Assessment Bodies on product risk assessment and regulatory implementation changes.
- Support regulatory matters related to custom import requirements and documentation.
- Assist and oversee matters involving licensed pharmacists or qualified personnel, including Poison A License and inspections by the Ministry of Health.
- Possess a Bachelor’s Degree in Science or a related discipline, with a minimum of 7 years of relevant experience in a similar capacity.
- Proficient in Microsoft Office applications, including Outlook, Excel, Word, and PowerPoint.
- Demonstrated track record in team leadership, preferably with experience managing a team of five or more, with strong people management capabilities including coaching and training.
- Excellent communication and interpersonal skills, with the ability to engage with regulatory authorities, consultants, auditors, and foreign manufacturers,effectively.
- In-depth knowledge and hands-on experience in medical device registration and regulatory compliance, particularly in Malaysia, Singapore, and Indonesia.
- Solid understanding of quality management systems, specifically ISO 13485, ISO 9001, and GDPMD requirements.
- Basic biomedical knowledge with the ability to understand and interpret technical aspects of medical devices.
- Strong understanding of operational workflows, with the ability to identify inefficiencies and implement process improvements.
- Meticulous and detail-oriented, capable of working independently with minimal supervision.
- Possess strong analytical and presentation skills, with the ability to translate data into meaningful insights.
- Proactive, performance-driven, and results-oriented, with a strong sense of ethical integrity and accountability in project execution.
- Pharmacist background with a valid license will be an added advantage.
Regulatory Affairs Specialist
Posted 2 days ago
Job Viewed
Job Description
Welcome diversity and apply as you are!
At Adisseo, we cherish the value of diversity whatever it may be.
By joining Adisseo , you will join committed people who make the difference every day to contribute to this challenge.
By joining Adisseo , you will integrate a dynamic international environment.
By joining Adisseo , you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.
Job Title : Regulatory Affairs Specialist
We are seeking a meticulous and proactiveRegulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.
Responsibilities
Key Responsibilities & Duties:
- Regulatory Compliance & Monitoring
- Maintain and update a centralized regulatory database to track product licenses, renewal deadlines, and compliance documents.
- Monitor regulatory updates from local country teams and assess their impact on business operations.
- Implement a tracking system to ensure timely renewals, submissions, and compliance with evolving regulations.
- Ensure proper implementation of global processes (e.g., labelling, document requests) and contribute to continuous improvement.
- Support by working with cross-functions to respond to customer audit purposes and regulatory agency queries.
- License & Registration Management
- Oversee end-to-end product registrations, including dossier preparation, submission, and follow-up with regulatory agencies.
- Renew licenses for existing products, ensuring adherence to labeling, MRL (Maximum Residue Limits), and safety requirements.
- Liaise with internal teams (R&D, Quality, Legal) and external stakeholders (regulatory bodies, third-party consultants) to resolve compliance issues.
- Prepare and submit regulatory dossiers for locally manufactured dilution products (Singapore-specific).
- Coordinate with Singapore authorities (e.g., SFA, NEA) to secure necessary approvals.
3. Documentation & System Maintenance
- Upload and maintain registration certificates, technical documents, and compliance records in the Product Lifecycle Management (PLM) system.
- Ensure data accuracy and completeness for audit readiness and regulatory inspections.
- Generate reports for management on registration statuses, expirations, and pending actions.
- Maintain records of formulation changes, batch records, and compliance certifications.
- Stakeholder Communication & Business Support
- Advise HQ, sales, and supply chain teams on regulatory considerations for:
- New product launches (e.g., registration pathways, labeling compliance)
- Product amendments (e.g., formulation changes, claims adjustments)
- Sharing of related information from local teams (eg. updated requirements for import/export from local teams).
- Respond to customer regulatory requests, including undesirable substances declarations, safety data sheets (SDS), and supplier compliance questionnaires.
- Prepare customized compliance statements for clients based on regional regulatory requirements.
- Hold monthly alignment calls with country regulatory teams and senior regulatory affairs executive to track registration progress and address challenges.
- Support sales and supply chain teams by providing regulatory guidance for product distribution and market access.
Qualifications
Qualifications & Skills:
Education & Experience:
- Bachelor’s/Master’s degree in Regulatory Affairs, Chemistry, Life Sciences, or a related field.
- 2-3 years of experience in regulatory affairs, preferably in agrochemicals, pharmaceuticals, or consumer goods.
- Experience with APAC regulatory frameworks (e.g., China, India, ASEAN) is a plus.
Technical Skills:
- Proficiency in regulatory databases (e.g., PLM, SAP) and MS Office (Excel, PowerPoint).
- Knowledge of GLP, GMP, and ISO standards for compliance documentation.
Soft Skills:
- Strong attention to detail – Ensures accuracy in submissions and compliance records.
- Proactive problem-solving – Anticipates regulatory hurdles and proposes solutions.
- Excellent communication – Clearly conveys complex regulations to non-experts.
- Collaborative mindset – Works effectively with cross-functional teams.
- Results-driven – Committed to meeting KPIs (e.g., on-time renewals, audit pass rates).
- Service-oriented – Supports internal teams with a solutions-focused approach.
- Long-term thinker – Aligns regulatory strategies with business growth.
Regulatory Affairs – Singapore
Posted 4 days ago
Job Viewed
Job Description
What to Expect
- Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
- Prepare and file global medical device applications and amendments, ensuring timely market access.
- Engage with regulatory authorities and distribution partnersto support product registrations
- Author and maintain EU MDR-compliant technical documentation, including notifications of change, and lead all EU regulatory initiatives.
- Conduct global regulatory impact assessmentsfor product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
- Act as the regulatory representative on cross-functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
- Interpret and apply international regulations, standards, and directivesto ensure ongoing global compliance.
- Review and approve product labelingto ensure compliance with global regulatory requirements.
- Support and participate in inspections and auditsconducted by global regulatory authorities.
Requirements
- Minimum 5 years of Experience
- Fluent English
If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) or email
Tagged as: Regulatory Affair
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