144 Medical Registration jobs in Singapore

Adept in medical device product registration and leading quality management initiatives.

Responsible for planning, organizing, and implementing the domestic registration of company products, developing product registration strategies, collaborating on research and development to prepare product technical requirements and other related testing/registration technical documents. Coordinate registration project resources and effectively promote the development of registration work.

Assist superiors in organizing internal registration management within the company, assist in establishing the necessary management system for registration, and establish and maintain a database of relevant product registration documents.

Timely understanding of changes in medical device regulations, real-time access to newly released and revised laws and regulations, and grasp the policy orientation and approval principles of product registration and application.

Collect, organize, and update the laws, regulations, and product standards related to the company, provide consulting advice for new product registration or certification strategies, and ensure product regulatory compliance after listing.

Adept in medical device product registration and leading quality management initiatives.
Responsible for planning, organizing, and implementing the domestic registration of company products, developing product registration strategies, collaborating on research and development to prepare product technical requirements and other related testing/registration technical documents. Coordinate registration project resources and effectively promote the development of registration work.
Assist superiors in organizing internal registration management within the company, assist in establishing the necessary management system for registration, and establish and maintain a database of relevant product registration documents.
Timely understanding of changes in medical device regulations, real-time access to newly released and revised laws and regulations, and grasp the policy orientation and approval principles of product registration and application.
Collect, organize, and update the laws, regulations, and product standards related to the company, provide consulting advice for new product registration or certification strategies, and ensure product regulatory compliance after listing.
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REGULATORY AFFAIRS - PROJECT COORDINATOR - 8 Months contract

• Duration: 8 months

• udget: Up to $6.2K

• T rget onboarding: November 2025

• L cation: north

• C ordinate regulatory projects within the IPRA team

encompassing end-to-end planning, timeline management, regulatory submissions, and cross-functional communication to ensure project milestones are met and issues are promptly resolved.

• P epare and draft essential regulatory documentation for product registration across various countries, including the generation of specification sheets for new product submissions.

• O ersee a range of operational activities including blue sheet evaluations, regulatory assessments, internal training facilitation, IPRA system initiatives, PIP registrations, and the management of licenses, product listings, and related documentation.

• C mpile and consolidate technical and managerial reports from internal departments to support timely and accurate product registration submissions.

• R view marketing materials and technical documentation to ensure alignment with APAC regulatory requirements and compliance standards.

• P rform due diligence on contractual agreements and supporting materials to safeguard intellectual property rights and uphold business interests.

• D liver secretarial and administrative support for PIP meetings, including agenda setting, documentation review, minute taking, and follow up circulation to stakeholders. Track project progress and coordinate monthly dissemination of relevant data and updates, while managing document reviews and approvals through the designated gatekeeping systems.

• P rform any additional ad-hoc or miscellaneous tasks as assigned by the manager to support team operations and project objectives.

Interested candidates, do submit your resume to: OR telegram @jocelynchan

Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)

Company EA Licence number : 99C4599

Personnel EA License: R1331820

Welcome diversity and apply as you are!
At Adisseo, we cherish the value of diversity whatever it may be.

By joining Adisseo , you will join committed people who make the difference every day to contribute to this challenge.
By joining Adisseo , you will integrate a dynamic international environment.
By joining Adisseo , you will discover a world full of opportunities for every stage of your career by being actor to your professional journey.

Job Title : Regulatory Affairs Specialist

We are seeking a meticulous and proactiveRegulatory Affairs Specialist to ensure compliance with global regulatory requirements and support business operations. This role involves managing licenses and registrations, advising internal stakeholders, and staying ahead of regulatory changes. This role will work closely with the regional regulatory team and report functionally to Senior Regulatory Affairs Specialist. The ideal candidate will be highly organized, possess strong analytical skills, and thrive in both independent and collaborative work environments.

Key Responsibilities & Duties:

1. 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.

1. 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.

1. 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 & 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.

Alcotech Pte Ltd specializes in Infectious Disease Kits and Medical Device Regulatory Affairs. We support medical device manufacturers in navigating complex regulatory landscapes and securing market access across Singapore and Southeast Asia.

We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs. The ideal candidate will manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy.

• Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
• Advise on regulatory strategy, product classification, labeling, and compliance requirements.
• Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
• Support post-market surveillance activities.
• Point of contact for manufacturers' regulatory team and regulatory authorities, ensuring smooth and timely registration processes.

• Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
• Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
• Ability in speaking Chinese is a requirement.
• Strong organizational and project management skills; able to handle multiple submissions simultaneously.
• Familiarity with Therapeutic Products License (TPL) is preferred.

• Office-based role
• Monday – Friday, 9:00 am – 6:00 pm
• Location: 25 Bukit Batok Crescent, #09-13 The Elitist, Singapore 658066

$4,100 – $5,300 monthly, based on experience

• Leverage your HSA or regulatory affairs experience to lead submissions across multiple medical device product lines.
• Work closely with clients and regulatory authorities in a high-impact role.
• Gain exposure to ASEAN regulatory environments while building professional expertise.
• Join a specialist regulatory company offering career growth and professional development opportunities.

The Regulatory Affairs Executive in Pharmaceuticals based in New Delhi, India, will report to the Head of Regulatory Affairs / Managing Director. You will be responsible for managing the preparation and submission of regulatory documentation to health authorities to support the development, approval, and maintenance of pharmaceutical products. Your role will ensure compliance with national and international regulatory requirements throughout the product lifecycle.

Your key responsibilities will include:

• Approving labels, packaging, and promotional materials for compliance
• Summarizing scientific data
• Preparing regulatory dossiers for new product approvals, renewals, and variations
• Ensuring timely submissions to regulatory agencies
• Managing communication with health authorities
• Tracking regulatory changes
• Reviewing product materials for compliance
• Supporting clinical trials
• Maintaining regulatory databases
• Collaborating with cross-functional teams

To qualify, you should hold a Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related field, along with 4-5 years of experience in pharmaceutical regulatory affairs. Strong knowledge of global regulatory requirements from FDA, EMA, ICH, CDSCO, etc., attention to detail, critical thinking, organizational skills, and excellent communication skills are essential.

Preferred qualifications include Regulatory Affairs Certification (RAC) or equivalent, familiarity with global submission platforms, and experience in new drug applications and post-marketing surveillance.

This is a full-time position offering benefits such as cell phone reimbursement, day shift schedule, and a performance bonus. If qualified and interested in contributing to regulatory strategies during drug development and post-marketing phases, we encourage you to apply.

For inquiries, please contact Tanveer Kaur, HR, at +91 97hidden_mobile 3.

• 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.
  

Job Title: Regulatory Affairs Specialist

Location: Singapore

About Us:

The company is a global pharmaceutical company with significant presence in Asia, with operations in multiple countries.

Key Responsibilities:

• Formulation of pharmaceutical strategies in collaboration with other teams and departments

• Monitoring and tracking of pharmaceutical operations at each local company

Qualifications:

• 2-3+ years of experience in pharmaceutical business

• Proactive, high level of initiative, communication/negotiation skills, logical thinking

Interested applicant, please click APPLY NOW

Do note that we will only be in touch if your application is shortlisted.

Peh Yong Sin
JAC Recruitment Pte Ltd
EA License Number: 90C3026
EA Personnel: R2197665

#LI-JACSG

#countrysingapore

About Soleil Collective

Backed by Gauge Capital, Soleil Collective is building a portfolio of leading high-growth brands specializing in sunless tan, suncare, and bodycare products. Soleil accelerates growth and improves profitability with sales, marketing, operations, and strategic management expertise. We have completed two acquisitions to date: Loving Tan and Coco & Eve.

Loving Tan is the category leader in prestige tanning, delivering the most natural-looking tan. Proudly made on Australia’s Gold Coast, the professional quality, natural olive color, and flawless application are beloved by A-listers, creators, and beauty lovers alike. Coco & Eve’s story starts in Bali, among volcanic beaches and lush rainforests. The brand offers sun-kissed, skin-loving tan products and deliciously scented, efficacious haircare formulated with tropical Balinese ingredients.

Responsibilities

Product Compliance

• Work with Brand and Product Development to ensure compliance of all new and existing products with global legislative requirements (FDA, EC, HSA, etc.).
• Complete registration of all new products/categories not covered by external regulatory partners.
• Liaise with regulatory agencies and manufacturers to resolve compliance issues and suggest corrective measures.
• Assist in substantiating product claims through research and provide evidence to Marketing and Brand teams.
• Support Product teams in quality-related matters, ensuring adherence to international standards and overall product compliance.

Business Development Compliance

• Provide guidance on regulatory requirements for entering new markets and channels.
• Evaluate compliance submissions from new retailers and act as the main contact until registration is complete.

Vendor Management

• Support the Operations Director in screening new suppliers and conducting due diligence.
• Define minimum factory compliance requirements (CSR), ensure conformity, and lead sustainability improvement initiatives.
• Coordinate with Legal and Quality teams to communicate requirements to trading partners and manufacturers.
• Collaborate with regulatory partners to develop a global compliance matrix for Soleil Collective’s current and future product categories and markets.