127 Regulatory Affairs Professionals jobs in Singapore

The Compliance Specialist role offers a great opportunity to work in the medical devices industry, ensuring product compliance with quality and regulatory requirements throughout development and transfer to production.

• Supports procedures to ensure compliance with Quality Systems and industry regulations during product development, maintaining an up-to-date Quality Management System aligned with current regulations.
• Collaborates with cross-functional teams and specification consultants to coordinate regulatory information, educating teams on Quality System requirements and conducting training sessions.

• Monitors and communicates updates on relevant regulations affecting product specifications, including efficacy and stability data, design history and development, technical construction documentation, risk management and clinical evaluation.
• Leverages expertise to establish and manage Technical Files for low to high-risk medical devices.

• Minimum 2 years of Quality and Regulatory experience in Medical or Pharmaceutical industry, with a good understanding of US, EU, HSA, and other regulations.
• Excellent communication skills for interacting with Health Authorities and Authorised Agencies.
• Internal Audit experience with knowledge of Singapore, Asia Pacific, and European regulatory requirements.

Overview
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 proactive Regulatory 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.
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Company Description
Poli Medical Company Pte Ltd, founded in 1971, began as a patent medicine manufacturer specializing in chinese pharmaceuticals and health supplements. Over the years, it has expanded to offer contract manufacturing/OEM services of private label health and food/health supplements and marketing/distribution of related products. Today, Poli Medical operates one of the few pharmaceutical manufacturing facilities in Singapore certified by the Health Authority of Singapore (HSA) with GMP standards. The company offers over 200 SKUs, with around 100 registered with local authorities, and its products are available in countries including most of south east asia, Europe and the United States.
Role Description
This is a full-time hybrid role for a Regulatory Affairs Specialist. The Regulatory Affairs Specialist will be responsible for preparing regulatory documentation, ensuring compliance with regulatory requirements, managing regulatory submissions, and maintaining updated knowledge of regulatory affairs. The role involves working from home part-time and is located in Singapore.
Qualifications
Experience in Regulatory Documentation, Regulatory Compliance, and Regulatory Requirements
Knowledge and experience in Regulatory Affairs and Regulatory Submissions
Strong analytical and problem-solving skills
Excellent written and verbal communication skills
Attention to detail and ability to work independently
Bachelor's degree in a relevant field such as Pharmacy, Life Sciences, or Chemistry
Experience in the pharmaceutical industry is a plus
Seniority level
Entry level
Employment type
Full-time
Job function
Legal
Pharmaceutical Manufacturing
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About ResMed

At ResMed, we pioneer innovative health technologies that transform millions of lives daily. From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes. We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.

Regulatory Affairs (RA) at ResMed is central to ensuring timely and compliant access to global markets. We work across more than 140 countries to deliver safe and effective innovations that improve quality of life. With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.

Team Overview

Regulatory Product Strategy & Delivery (RPSD) (Singapore).

The Singapore RPSD team leads regulatory strategy and delivery for products where ResMed Singapore is the legal manufacturer. The team supports New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects, enabling global submission readiness, risk assessments, and regional collaboration.

As an individual contributor in this team, the Specialist, Regulatory Product Strategy & Delivery – Singapore will partner with cross-functional stakeholders to ensure design, documentation, and change activities meet regulatory expectations across all key markets (e.g., US, EU, APAC, LATAM)

Position Summary

As a Specialist, Regulatory Product Strategy & Delivery – Singapore, you will contribute directly to the successful delivery of regulatory strategy, submission documentation, and change management activities for Singapore-manufactured devices and accessories.

You will represent Regulatory Affairs on cross-functional teams and collaborate with global RA colleagues to ensure alignment, accuracy, and traceability across submissions and product lifecycle updates. This is a critical role in ensuring regulatory quality, efficiency, and global market continuity.

Key Responsibilities

1. Regulatory Strategy & Execution

• Support regulatory strategy development and documentation for NPI and PLE projects led by the Singapore RPSD team.
• Participate in the preparation, review, and submission of global regulatory filings including 510(k), CE MDR, TGA, Health Canada, and regional registrations.
• Contribute to authoring of submission content such as labelling justifications, equivalence arguments, standards declarations, and technical summaries.

2. Product Change Support

• Evaluate the regulatory impact of product and design changes via DCA/CPA frameworks, contributing to global significance assessments and risk mitigation actions.
• Review and update technical file documentation, declarations, and certificates in collaboration with the Regulatory Foundations team.
• Track submission timelines and deliverables using Jira and other RA platforms.

3. Cross-Functional Collaboration

• Represent Regulatory Affairs in cross-functional project teams involving engineering, clinical, quality, labelling, and supply chain.
• Participate in design reviews, change assessments, and internal risk forums as the RA contributor for Singapore-based products.
• Collaborate with Regional RA and global RPSD counterparts to ensure harmonization of documentation and submission approaches.

4. Regulatory Systems & Process Improvement

• Maintain accurate regulatory records and document control through RIMSYS, Confluence, and SharePoint tools.
• Support continuous improvement activities by contributing to template updates, process harmonization, and RA onboarding content.
• Assist in audit readiness activities and postmarket traceability tasks as needed.

5. Other Duties and Requirements

• Perform additional responsibilities as required to support RA and RPSD objectives.
• Contribute to process improvements and special projects across Regulatory Affairs.
• Support inspections, audits, and team collaboration activities.

Qualifications & Experience

Required

• Bachelor's degree in engineering, life sciences, health policy, or a related field.
• 3+ years of experience in Regulatory Affairs or a compliance-related role within a regulated industry (preferably medical devices).
• Familiarity with product development under design control and regulatory frameworks (e.g., ISO 13485, ISO 14971, 21 CFR 820).
• Strong communication, organization, and document review skills.
• Ability to manage multiple priorities, meet deadlines, and operate effectively in a cross-functional team environment.

Preferred

• Experience preparing or contributing to global regulatory submissions (e.g., FDA 510(k), EU MDR, TGA).
• Understanding of Singapore-specific regulatory frameworks and product license processes.
• Familiarity with submission and documentation tools such as Jira, RIMSYS, and Confluence.
• Experience supporting Class II or III medical devices in respiratory or digital health fields.

Who You Are

You are a regulatory problem-solver and proactive collaborator. You bring technical curiosity and process discipline to your work, with a sharp eye for detail and a strong sense of responsibility for quality. Whether it's preparing documentation, clarifying regulatory pathways, or contributing to design decisions—you show up with clarity, consistency, and a drive to improve.

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now

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)

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

Job title: Regional Regulatory Affairs Specialist

Reference ID: 36639

Our client, a Japanese pharmaceutical company, is currently seeking to hire a Regional Regulatory Affairs Specialist to support operations across Asia and the ASEAN region. The primary responsibilities of this role include coordinating regulatory submissions, supporting strategy development, and monitoring activities across local affiliates.

You will be reporting to the eam Leader (Singapore).

【 Responsibilities 】

- Regulatory coordination with local Responsible Persons

- Documentation & dossier management (ASEAN CTD, eCTD)

- Compliance oversight & regulatory intelligence

- Stakeholder engagement across multiple internal teams

- Lifecycle management and post-approval changes

- Electronic submission systems / regulatory tracking tool usage

【 What you will receive 】

- AWS

- Variable Bonus (Depends on Company and Individual performance)

- Annual Leave 14 days

- Medical Leave

- Medical Benefits

- Flexible Benefits (S$1500/year)

- WFH: Once a week to be at Office, others day WFH

【Requirements & Preferences】

(Must)

- Bachelor's or Master's in Pharmacy, Life Sciences, or related field

- Minimum 3 years of experience in Regulatory Affairs within Singapore's pharmaceutical industry.

- Familiarity with ASEAN CTD, ICH, country-specific regulations

- Proficiency in both written and spoken English is required to liaise with counterparts and handle documentation.

- Proactive, self-motivated, and able to take initiative with high energy levels.

(Advantageous)

- Possess regional exposure in APAC

- Strong communication and negotiation skills.

- Logical thinking and sound problem-solving capabilities.

- Ability to adapt well to changes and work effectively under pressure.

- Possess regional experience in a large pharmaceutical company is an advantage.

We regret that only shortlisted candidates will be notified.

Registration No.: R Stanley Neo Khay Liang)

Recruitment Licence: 12C5051