141 Regulations jobs in Singapore

Officer, Regulations

$30000 - $60000 Y NTUC FIRST CAMPUS LIMITED

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Job Description

At NTUC First Campus, we offer more than jobs—we provide rewarding careers that prioritise your growth and well-being. As a People First organisation, we empower you to thrive and make a meaningful impact.

Our family of preschools and services—including My First Skool, Little Skool-House, Outdoor School Singapore, and Bright Horizons Fund—supports young families and strengthens communities. Whether you're shaping young minds, driving innovative educational practices, or supporting families, every role here offers the chance to make a genuine difference.

When you join us, you'll find a supportive community and a dynamic environment that values your unique contributions and helps you realise your potential. Together, let's enable bright futures for every child and family.

We are seeking a highly organized and detail-oriented Officer to support the Operations & Regulations Team in collecting and consolidating data and/or information, and acting as a liaison between internal teams and external partners.

This role requires someone who has strong communication skills, a high level of organization, and the ability to handle multiple tasks simultaneously.

Job Responsibilities:

  • Information Consolidation: Collect and compile data for reports or presentations as requested. Ensure that all information collected is accurate and presented clearly.
  • Report Preparation: To assist the Executives in preparing regular and ad-hoc reports on key metrics, operational progress, and any other relevant data.
  • Liaison and Coordination: Liaise with both external and internal stakeholders such as NAC, NEA, etc. to gather accurate information and/or data. Internal stakeholders include Centre and HQ colleagues such as Admin, Finance, CSS, etc.
  • Independent Work: Take initiative in managing tasks and projects independently, prioritizing work based on urgency and importance.
  • Data Accuracy & Quality: Check information and/or data is accurate before handing it over to the Executives for their reporting.
  • Confidentiality & Compliance: Ensure all sensitive information is handled according to company guidelines and legal requirements, maintaining confidentiality at all times.

Job Requirements:

  • Diploma holders with 1 to 2 years of working experience.
  • Proven experience in an administrative or clerical role is an advantage.
  • Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
  • Strong attention to detail with the ability to handle large volumes of information accurately.
  • Excellent written and verbal communication skills, with the ability to effectively liaise with various internal and external parties.
  • Strong organizational and time-management skills with the ability to prioritize tasks.
  • Ability to work independently and as part of a team.
This advertiser has chosen not to accept applicants from your region.

Financial Regulations Specialist

Singapore, Singapore beBeeCompliance

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Job Description

Compliance Professional Role Overview ", "

The Compliance Manager plays a pivotal role in ensuring organizational compliance with anti-money laundering (AML) and know-your-customer (KYC) regulations. This position involves reviewing high-risk customer onboarding, providing AML/KYC advisory services, and overseeing ongoing monitoring of account relationships.

", "Key Responsibilities: ", "
  • Reviewing and approving high-risk customer onboarding.
  • Providing AML/KYC advisory services on name screening, KYC documentation, and onboarding issues/red flags escalated by frontline staff.
  • Obtaining senior management approval for establishing or continuing business relations with high-risk rated customers.
  • Overseeing ongoing monitoring of account relationships.
  • Maintaining and updating local internal blacklists in the AML system.
  • Participating in system implementation and UAT, system enhancements, identification of system gaps, and evaluation of system capabilities/functionalities to enhance control effectiveness and efficiency.
", "Required Skills and Qualifications: ", "
  • A recognized university degree or relevant professional qualifications in financial services or audit.
  • 6-8 years' experience in AML compliance within the banking, digital assets, and/or relevant fields.
  • Familiarity with payments and cryptocurrency AML and sanctions programs.
  • Familiarity with MAS regulations in relation to ML/TF.
  • Interest in digital payment tokens and/or DPT service providers.
  • Good interpersonal and communication skills.
  • Resilience and ability to take criticism.
  • Adaptability, proactivity, independence, and resourcefulness.
", "

By submitting your application, you consent to the collection, use, and retention of your data according to our prevailing data retention and PDPA policies.

", "Benefits: ", "

This role offers opportunities for growth, development, and contributions to an organization dedicated to regulatory compliance and excellence.

", "Others: ", "

Please note that this information is subject to change, and we reserve the right to modify our policies and procedures as needed.

This advertiser has chosen not to accept applicants from your region.

Financial Regulations Investigator

Singapore, Singapore beBeeCompliance

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Job Description

Investigation Manager

We are seeking an Investigation Manager to lead end-to-end market conduct investigations and ensure regulatory compliance.

  • This role involves conducting periodic audits to identify key risk areas, implementing policies to address risks, and providing trainings as required to ensure compliance across the organization.

To succeed in this role, you will need:

  • A degree with at least 2+ years of experience performing investigations in an insurance company, police, or financial institution.
  • A strong understanding of relevant legislation in the area.
  • Excellent communication skills.

We offer a competitive remuneration package, flexible working arrangement, and opportunities for professional growth and development.

This advertiser has chosen not to accept applicants from your region.

Manager - Regulations, Risk & Compliance

Singapore, Singapore SPH Media

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Job Description

Overview
At SPH Media, we create remarkable content and experiences – from breaking news to lifestyle content, reaching our audiences on a range of different platforms. As Asia’s leading media organisation, our mission is to be the trusted source of news on Singapore and Asia, to represent the communities that make up Singapore, and to connect them to the world.
Roles and Responsibilities
Governance and Policy Development: Develop, review and maintain enterprise-wide information security framework, policies and standards aligned with industry standards and best practices, regulatory obligations and business objectives. Collaborate with stakeholders across the organization to ensure policies are effective, relevant and enforced. Drive organization-wide awareness and adoption of cybersecurity policies, procedures, and regulatory expectations.
Data Security & Governance: Contribute to Data Governance initiatives, including the creation and implementation of policies on data classification, handling, storage, retention, and disposal. Ensure data security controls are in place to support privacy, confidentiality, and regulatory requirements. Oversee and maintain the organization’s compliance with the Personal Data Protection Act and other relevant data protection laws. Manage data breach notifications and communication with regulatory authorities. Conduct cybersecurity risk assessments for both IT and OT environments; identify, document, and monitor cybersecurity risks across the enterprise. Develop, maintain, review and report on the Cybersecurity Risk Register. Coordinate and participate in periodic risk self-assessments, and monitor the progress of remediation action plans. Prepare and deliver detailed risk reports and treatment plans for senior management and relevant regulatory authorities.
Audit & Regulatory Support: Act as a primary liaison with internal and external auditors, regulatory bodies, and compliance stakeholders for audits and assessments involving cybersecurity domains. Prepare documentation and evidence, coordinate audit responses, and manage remediation activities post-audit.
Continuous Improvement & Industry Alignment: Lead cybersecurity maturity assessments and benchmark organizational posture against recognized frameworks. Recommend and drive continuous improvements to GRC processes based on industry best practices, risk trends, audit findings, and evolving threats. Stay informed of emerging regulatory requirements, cyber threats, and innovations in cybersecurity governance.
Qualifications and Education Requirements
Degree or higher in Cybersecurity, Computer Science, Engineering, or Information Systems
Work Experience: 5-7 years in delivering projects in areas such as security governance, audit, vulnerability assessments, security operations, incident response, security risk management and risk management tools
Familiarity with supporting enterprise information applications and infrastructure (e.g. server, network, database and Cloud)
Good working knowledge of security risk management and security governance methodologies, industry security standards such as ISO27001/2, CIS Critical Controls, NIST Cybersecurity Framework, risk management tools, technical vulnerability management, security technologies and trends and security operations
Ability to work independently and collaboratively across functional teams
Preferred Skills
Strong analytical, documentation, and stakeholder engagement skills
Be able to present assessment and review results (either verbally or via a well-written report) in an articulate and clear manner, to both technical and non-technical stakeholders
Good knowledge and experience with Cybersecurity Act in Singapore, Cybersecurity Code of Practice (CCoP) for CII and Personal Data Protection Act (PDPA)
Preferred certifications: CISSP, CISM, CISA, CRISC or equivalent GRC-related certifications
Seniorities and Employment
Seniority level: Mid-Senior level
Employment type: Full-time
Job function: Information Technology
Industries: Media Production
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Regulatory Affairs

$120000 - $180000 Y SEARCH STAFFING SERVICES PTE. LTD

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Job Description

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager. This is a newly created headcount in Singapore.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

  • Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
  • Interpret and apply global medical device regulations and standards.
  • Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East, etc.).
  • Maintain regulatory intelligence and proactively communicate changes to the organization.
  • Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
  • Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

  • Serve as the QMS Management Representative as required by ISO 13485.
  • Maintain and continuously improve the QMS to ensure ongoing compliance with ISO 13485, EU MDR and FDA 21 CFR Part 820.
  • Lead internal audits, management reviews, and risk management activities.
  • Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
  • Monitor and report on QMS performance metrics and key quality indicators (KPIs).
  • Ensure proper document control and change management processes are implemented.
  • Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

About the company:

  • American startup with senior management team; based in US, Europe and Singapore
  • Hybrid work arrangement – 2 days in office, 3 days working from home
  • Excellent medical insurance coverage
  • Good variable bonus structure
  • Great working culture
  • Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at

EA Personnel Registration No: R

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs

$120000 - $200000 Y Terumo

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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)

This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs

Singapore, Singapore $120000 - $150000 Y Search staffing services pte ltd

Posted today

Job Viewed

Tap Again To Close

Job Description

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

  • Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
  • Interpret and apply global medical device regulations and standards.
  • Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
  • Maintain regulatory intelligence and proactively communicate changes to the organization.
  • Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
  • Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

  • Serve as the QMS Management Representative as required by ISO 13485.
  • Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
  • Lead internal audits, management reviews, and risk management activities.
  • Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
  • Monitor and report on QMS performance metrics and key quality indicators (KPIs).
  • Ensure proper document control and change management processes are implemented.
  • Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

About the company:

  • American startup with senior management team; based in US, Europe and Singapore
  • Hybrid work arrangement – 2 days in office, 3 days working from home
  • Excellent medical insurance coverage
  • Good variable bonus structure
  • Great working culture
  • Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at

EA Personnel Registration No: R

This advertiser has chosen not to accept applicants from your region.
Be The First To Know

About the latest Regulations Jobs in Singapore !

Regulatory Affairs

Singapore, Singapore SEARCH STAFFING SERVICES PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:
  • Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
  • Interpret and apply global medical device regulations and standards.
  • Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
  • Maintain regulatory intelligence and proactively communicate changes to the organization.
  • Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
  • Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).
Quality Management System (QMS):
  • Serve as the QMS Management Representative as required by ISO 13485.
  • Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
  • Lead internal audits, management reviews, and risk management activities.
  • Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
  • Monitor and report on QMS performance metrics and key quality indicators (KPIs).
  • Ensure proper document control and change management processes are implemented.
  • Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.
About the company:
  • American startup with senior management team; based in US, Europe and Singapore
  • Hybrid work arrangement - 2 days in office, 3 days working from home
  • Excellent medical insurance coverage
  • Good variable bonus structure
  • Great working culture
  • Excellent office location (Central - just beside MRT)
Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at .

EA Personnel Registration No: R
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs

Singapore, Singapore TERUMO ASIA HOLDINGS PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

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)
This advertiser has chosen not to accept applicants from your region.

Regulatory Affairs

Singapore, Singapore SEARCH STAFFING SERVICES PTE. LTD.

Posted today

Job Viewed

Tap Again To Close

Job Description

Roles & Responsibilities

Our client is an exciting American medical devices startup in the field of pregnancy assisted birthing instruments. The company is rapidly expanding its operations here in Singapore and is looking for the position of Regulatory Affairs & QMS Manager.

Regulatory Affairs & QMS Manager.

Reporting to the Chief QARA Officer (Based in Singapore), you will be responsible for:

Regulatory Affairs & Compliance:

  • Serve as the Person Responsible for Regulatory Compliance (PRRC) under Article 15 of the EU MDR for full or selected scope of responsibility.
  • Interpret and apply global medical device regulations and standards.
  • Lead the preparation and submission of regulatory dossiers and product registrations (e.g., CE Mark Technical Documentation, Asia, Middle East etc.).
  • Maintain regulatory intelligence and proactively communicate changes to the organization.
  • Collaborate with marketing and commercial teams to ensure labelling, instructions for use (IFU), and advertisements meet internal regulatory and quality requirements.
  • Review and approve global marketing and promotional materials to ensure consistency with approved product claims and compliance with regional regulatory requirements (e.g., EU MDR, FDA advertising and promotional guidelines, and other global standards).

Quality Management System (QMS):

  • Serve as the QMS Management Representative as required by ISO 13485.
  • Maintain and continuously improve the QMS to ensure ongoing compliance with ISO13485, EU MDR and FDA 21 CFR Part 820.
  • Lead internal audits, management reviews, and risk management activities.
  • Drive corrective and preventive action (CAPA) systems and support root cause analysis efforts.
  • Monitor and report on QMS performance metrics and key quality indicators (KPIs).
  • Ensure proper document control and change management processes are implemented.
  • Develop, coordinate, and conduct QMS training programs, including onboarding and regular refresher sessions, to ensure employee's understanding and compliance with quality procedures and regulatory requirements.

About the company:

  • American startup with senior management team; based in US, Europe and Singapore
  • Hybrid work arrangement – 2 days in office, 3 days working from home
  • Excellent medical insurance coverage
  • Good variable bonus structure
  • Great working culture
  • Excellent office location (Central – just beside MRT)

Interested applicants, kindly send in a copy of your updated resume in WORD document to stating your current and expected remuneration together with notice period required to current employer.

You can also contact Vincent Low for a confidential discussion at .

EA Personnel Registration No: R

Tell employers what skills you have

Technical Documentation
CAPA
FDA
Regulatory Compliance
Quality Management
Change Management
Regulatory Affairs
ISO
Root Cause Analysis
Risk Management
Compliance
Medical Devices
ISO-13485
Audits
EMDR
QMS, Quality Management Systems
Regulatory Requirements
QMS Audit
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  61. science Scientific Research & Development
  62. wifi Telecoms
  63. psychology Therapy
  64. pets Veterinary
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