514 Customs Regulations jobs in Singapore

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

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

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)

Job Responsibilities

• Implement strategies for regulatory approval and ensuring compliance with regional and international regulations for all product categories of the company.
• Develop a comprehensive understanding and maintain current knowledge of the regional and international regulations and standards applicable to the company products.
• Co‑ordinate, prepare, submit and follow up registration applications to regional authorities within the stipulated timeline, and to high standards, to ensure that market permissions are obtained and maintained in line with the company’s plans.
• Liaise with suppliers/contract manufacturers for documents required for product registration and other related regulatory matters.
• Ensure timely registration or license renewal of products and that submissions meet strict deadlines.
• Maintain and update requirements for labelling and consolidated standards of regulatory safety limits applicable to the company products.
• Review labelling, summary of product characteristics and marketing material to ensure compliance with current legislation and registered particulars and take action.
• Maintain and implement the product artwork and label management system.
• Maintain an internal finished product and ingredient database.
• Keep up to date with changes in regulatory legislation, guidelines and best practices, provide updates and assess the impact of these changes on the products or the company.
• Implement and update standard procedures for, monitor and ensure timely completion of reactions to regulatory requirement changes.
• Foster collaborative, efficient and effective working relations, liaise and negotiate with regulatory authorities such as the HSA, SFA, regulatory agencies and industrial associations.
• Give regulatory advice, develop and maintain links to other teams (including product, quality, supply chain, logistics, marketing, design) so that appropriate development, quality or marketing plans may be established.
• Ensure best practice for filing/archiving of relevant product correspondence; create and update Product Information Files to high standards.

• Degree in science, preferably in chemistry, biochemistry, pharmacy, biomedical science, cosmetic science or similar
• Proven relevant experience within the regulatory environment
• Proven familiarity and experience in the cosmetic, health food, dietary supplement, pharmaceutical or other FMCG industry
• Experience in ASEAN TMHS and/or cosmetic regulations, including PIF handling, is preferred
• Self‑starter, good at working well independently with initiatives
• Meticulous & detail‑oriented
• Planning & organising skills; time management skills
• Communication & negotiation skills
• Analytical & problem‑solving skills

Job Responsibilities

• Implement strategies for regulatory approval and ensuring compliance with regional and international regulations for all product categories of the company.
• Develop a comprehensive understanding and maintain current knowledge of the regional and international regulations and standards applicable to the company products.
• Co‑ordinate, prepare, submit and follow up registration applications to regional authorities within the stipulated timeline, and to high standards, to ensure that market permissions are obtained and maintained in line with the company’s plans.
• Liaise with suppliers/contract manufacturers for documents required for product registration and other related regulatory matters.
• Ensure timely registration or license renewal of products and that submissions meet strict deadlines.
• Maintain and update requirements for labelling and consolidated standards of regulatory safety limits applicable to the company products.
• Review labelling, summary of product characteristics and marketing material to ensure compliance with current legislation and registered particulars and take action.
• Maintain and implement the product artwork and label management system.
• Maintain an internal finished product and ingredient database.
• Keep up to date with changes in regulatory legislation, guidelines and best practices, provide updates and assess the impact of these changes on the products or the company.
• Implement and update standard procedures for, monitor and ensure timely completion of reactions to regulatory requirement changes.
• Foster collaborative, efficient and effective working relations, liaise and negotiate with regulatory authorities such as the HSA, SFA, regulatory agencies and industrial associations.
• Give regulatory advice, develop and maintain links to other teams (including product, quality, supply chain, logistics, marketing, design) so that appropriate development, quality or marketing plans may be established.
• Ensure best practice for filing/archiving of relevant product correspondence; create and update Product Information Files to high standards.

• Degree in science, preferably in chemistry, biochemistry, pharmacy, biomedical science, cosmetic science or similar
• Proven relevant experience within the regulatory environment
• Proven familiarity and experience in the cosmetic, health food, dietary supplement, pharmaceutical or other FMCG industry
• Experience in ASEAN TMHS and/or cosmetic regulations, including PIF handling, is preferred
• Self‑starter, good at working well independently with initiatives
• Meticulous & detail‑oriented
• Planning & organising skills; time management skills
• Communication & negotiation skills
• Analytical & problem‑solving skills

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities’ submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.

Responsibilities

1. Support development and execution of regulatory strategies aligned with Haw Par’s strategic priorities.
2. Prepare regulatory dossiers for new registrations, variations and renewal submissions to authorities in compliance with current regulatory requirements.
3. Collaborate with cross-functional teams including Marketing, Quality, R&D and subsidiary sites’ RA team, and external stakeholders to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.
4. Monitor and report submission statuses in real time using the RA department’s project management tools; proactively follow up, anticipate potential issues, and implement solutions (in consultation with supervisor) to ensure timely approvals.
5. Communicate regulatory approvals promptly to cross-functional teams and ensure accurate documentation of approval records in regulatory databases and repositories.
6. Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.

1. Bachelor’s degree in Pharmacy, Chemistry or Lifesciences.
2. Minimum 2 years of relevant experience in a regulated environment, preferably in OTC, cosmetics, or consumer health products.
3. Familiarity with ASEAN/EU and ICH regulatory guidelines.
4. Experience with European cosmetics and herbal products is an advantage.
5. Detail-oriented and proactive, with strong analytical skills and excellent written and verbal communication abilities.
6. A collaborative team player with strong interpersonal skills; able to manage multiple tasks and projects simultaneously with effective time management.

• 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.
  

• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Oversee documentation efforts to ensure compliance with local and international regulations and standards. Develop and maintain standard operating procedures.
• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Review materials such as marketing literature or user manuals to ensure that regulatory requirements are met.
• Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
• Participate in the development or implementation of clinical trial products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory authorities.
• Provide responses to regulatory authority regarding product information or issues.
• Review all regulatory authorities' submission materials to ensure timeliness and accuracy.
• Communicate regulatory information to relevant departments and ensure that information is interpreted correctly.