31 Regulatory Affairs Associate 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.

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

• 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.

Job Responsibilities

1. Product registration: including preparation of registration dossier, design of performance evaluation study and manage execution and communication with CRO (clinical research organization).
2. Be the subject matter expert on medical devices laws and regulations for product registration in company's regions of interest.
3. Interface the communication with regulatory agencies, e.g. Health Science Authority, Medical Device Authority, Food and Drug Administration, track the progress of product registration, and resolve problems raised by reviewers during the review process.
4. Involve in the process of product testing, clinical verification, data collection and relevant tracking.
5. Submit to agencies scientific special projects on behalf of the company.
6. Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies.
7. Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
8. Any other ad-hoc duties or projects as required by the management team.

1. A bachelor's degree in in Life Sciences, Pharmacy, or a related field
2. Familiar with ISO13485 quality management system, solid medical device quality management qualifications, including but not limited to Class B, C and D medical devices.
3. Expert in medical device product registration laws and regulations, able to independently draft registration dossier.
4. You shall have complete registration experience of Class B, C and D medical devices.
5. Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc.
6. Familiar with IVD product development and commercialization life cycle.
7. Systematically project management, good planning, execution and timely communication. Good presentation skills.
8. Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player.
9. Meticulous and strong sense of responsibility; able to handle stress and tight schedule.

A great opportunity to be part of a dynamic and progressive mid-size SME healthcare provider with a regional presence, as MD Pharmaceuticals Pte Ltd continues on its growth and expansion plans in Singapore, Malaysia, Hong Kong, Thailand, Myanmar and other parts of Asia in the coming years.

MD Pharmaceuticals Pte Ltd is now seeking to hire:

• Regulatory Affairs Pharmacist & Products Specialist (Pharmaceuticals products)

Unlike regular one-dimensional Pharmacist roles, the above position will enable the successful candidates to have more exposure to the related fields of Regulatory Affairs, Sales/Marketing & Business Development in the pharmaceutical industry.

The role is also based locally. However, there will be opportunities for overseas exposure and career advancement if the individual can prove himself /herself through solid work performance.

___

Main responsibilities:

• Assist with regulatory affairs and compliance work for the company's operations in Singapore and the Asian region, including dealing with product suppliers and regulatory bodies like HSA
• Actively stay updated and provide guidance on clinical information related to the company's suite of products, comprising both therapeutic drugs and healthcare supplements
• Drive the sales and marketing efforts of our products by gathering market/competitor information & proposing creative and feasible ideas as well as content to grow the sales and market share of our existing products
• Suggest and look into bringing in new potential products based on up-to-date market research and strong clinical evidence
• Gain a holistic understanding of the medical industry through practical sales and marketing outreach to develop the company's existing client base
• Establish sincere and professional relationships with healthcare professionals as well as key opinion leaders in the healthcare industry
• Assist with product trainings and provide related support to the Sales team
• Handle other duties as assigned

Key requirements:

• Must have at least a Bachelor's Degree in Pharmacy/Pharmacology, with a valid Pharmacist License registered under the Singapore Pharmacy Council
• Practical experience in the healthcare industry, including interaction with patients and healthcare professionals, would be beneficial
• Interested in Sales & Marketing/Business Development with an ability to apply clinical knowledge to better achieve sales and marketing outcomes
• Ability to work independently as well as in a team, including across different cultures and functions
• Solid communication skills, especially in both written and oral English. Working language proficiency in Mandarin/Thai would be an additional advantage for work-related translation purposes.
• Strong interpersonal skills, including ability to convince key stakeholders
• Positive, results-driven with a responsible attitude. Having own initiative is important for this role.
• Any Graphics Design skills, together with the knowledge of softwares such as Adobe Illustrator and Photoshop, etc. would be an advantage.

Interested candidates, please submit your updated resume & expected salary to us through the "Apply Now" button.

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

Job Description

Job Scope:

• Cosmetic Notification
• Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
• Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.
• Database Management
• Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.
• Support Regulatory Compliance Checks
• Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.
• Cross-functional Coordination
• Liaise with Brand to gather required information related to product notification and marketing claim review.

Qualifications

• Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.
• Able to commit full time internship from Oct 2025 to Mar 2026
• Detail-oriented, organized, and able to manage multiple tasks.
• Proficient in Excel.
• Good communication skills (written and verbal).

Job Description

Job Scope:

Cosmetic Notification

• Documentation preparation: Assist in collecting, organizing product information and technical documents required for cosmetic notification.
• Regulatory submission: Support the submission of cosmetic product notifications to relevant regulatory authorities or online portals. Track and update submission status and follow up on pending applications.

Database Management

• Maintain and update internal databases or trackers for product notifications, approvals, and related correspondence.

Support Regulatory Compliance Checks

• Conduct first-line marketing claims review in accordance with the acceptable/prohibited claim list published by the authority.

Cross-functional Coordination

• Liaise with Brand to gather required information related to product notification and marketing claim review.

Qualifications

• Undergraduate or recent graduate in Pharmacy, Chemistry, Life Sciences, or related field.

• Able to commit full time internship from Oct 2025 to Mar 2026

• Detail-oriented, organized, and able to manage multiple tasks.

• Proficient in Excel.

• Good communication skills (written and verbal).

At LVMH, people make the difference in the art of crafting dreams.

Our people fuel our dynamic, entrepreneurial culture. We value collective ambitions, encouraging our talents to push boundaries and champion a curious, audacious state of mind. Our commitment to excellence is reflected in nurturing every individual with a growth mindset and development opportunities, consistently empowering them to reach their full potential. We are actively committed to positive impact through an inclusive environment that supports and gives back to our talented community.

Join us at LVMH, where your talent is at the heart of our collective successes.

Job Description

• Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets
• Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on guiding projects from initial concept to market delivery.
• Direct and manage cross-functional teams for regulatory submissions, fostering relationships with senior leadership and ensuring regulatory milestones are met.
• Monitor the development of regulatory submission plans for pivotal projects/products, maintaining a clear trajectory from inception through to successful project completion.
• Provide strategic leadership to the Regional Regulatory team, Health Authorities, and external partners, ensuring quality and compliance in all outsourced activities.
  Act as a mentor and coach, empowering team members with enhanced skills in project management, publishing, and regulatory practices, driving projects from their commencement to their conclusion.

Requirements

• Possess a bachelor's degree in a scientific or related field.
• Bring a minimum of 10 years of regulatory affairs experience within the pharmaceutical industry, with a substantial focus on managing the full lifecycle of regulatory strategies and submissions.
• Demonstrate an extensive understanding of regulatory requirements and guidelines within the Asia Pacific region, adaptable to the regulatory environments of the expanding MENA market.
• Have a proven ability to lead and manage cross-functional teams and navigate complex regulatory submissions from inception to completion.
• Exhibit superior project management skills, with a history of achieving key project milestones and delivering projects to completion.
• Maintain strong leadership and communication abilities, capable of influencing senior stakeholders and leading a team in a high-performance culture.
• Display commitment to professional development of team members, with a track record of mentoring and driving performance.
• Utilize excellent organizational skills to manage multiple projects simultaneously, ensuring attention to detail and a solution-oriented mindset.

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.

Requirements

• 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, pharmaceuticalor 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