Regulatory Affairs Specialist

7 days ago


Singapore INTEGRITY PARTNERS PTE. LTD. Full time

We are representing an esteemed Medical Devices Company, who is seeking a Regulatory Affairs Specialist to join their team. This successful incumbent will be responsible for developing and implementing effective regulatory strategies and processes to support the timely registration of new products, life cycle management and post-market activities.

You should possess strong negotiation and facilitation skills, and the ability to articulate well and promote effective discussions and collaboration across departments. You should also have strong time management and project management skills with great attention to details.

**RESPONSIBILITIES**
- Recommend strategies to the business units to resolve issues related to regulatory pre-market activities and promote strong partnerships to drive implementation and resolution.
- 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.
- Effective communication between global, HQ RA and manufacturing sites' RA to ensure implementation of all strategic plans.
- Coordinate with Regulatory Affairs in the manufacturing sites, CRAO and HQ RA to ensure optimal, efficient, and compliant registration and QA reporting.
- Lead and drive RA/QA activities in accordance with local requirements to ensure the Company’s products are registered on time or life cycle management in the markets are in scope of responsibility, and post marketing surveillance risks are minimized.
- Responsible for Regulatory monitoring and analysis of new or updated local legislation and for assuring in-time registration in the relevant countries.
- Create a regulatory plan and a labelling plan (when needed) to ensure consistency and guidance to the market introduction projects.
- Improve efficiency of RA team to create a cogent process of documents/data management / storage and / or document flow which is easy and efficient for access to relevant stakeholders.
- To provide training and knowledge sharing session to the Company’s associates and distributor to ensure all parties understand and comply to all relevant local regulations.
- Responsible to monitor distributor’s competencies in regulation activities, and to provide effective solution to ensure quality RA work could be carried out.

**EDUCATION AND EXPERIENCE NECESSARY**
- Relevant science degree (e.g., Pharmaceutical/Life Sciences/Biomedical Engineering)
- At least 1 to 3 years of regulatory affairs experience in handling product registration and license maintenance
- High level of regulatory knowledge, preferably in the APAC/ASEAN context

Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502



  • Singapore Ethos BeathChapman Full time

    **Job Details**: **Location** Singapore **Salary** Competitive Salary **Job Type** Permanent **Ref** BH-179384 **Contact** Roselle Cuntapay **Posted** about 3 hours ago - Currently recruiting for a Regulatory Affairs Specialist for a small Medical Device business. Their product is currently in a couple of markets (and doing well) but they are...


  • Singapore Johnson & Johnson Full time

    Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of...


  • Singapore BLUE EDGE ADVISORS PTE. LTD. Full time

    The Regulatory Affairs Specialist will be responsible for ensuring that Blue Edge Advisors remains compliant with all relevant laws and regulations. This includes developing, maintaining, and updating compliance policies and procedures, as well as coordinating the management of regulatory inspections, audits, and reviews. The ideal candidate will have a good...


  • Singapore MERIT MEDICAL SINGAPORE PTE. LTD. Full time

    **PURPOSE OF JOB** Subject matter expert in determining the current regulatory requirements and strategies for Merit Medical Singapore design control projects. Prepare documents and /or submission required to obtain clearance or approval from government agencies for commercial distribution of Merit’s Medical Devices. Key government agencies with direct...


  • Singapore SINGAFUTURE PTE. LTD. Full time

    We are looking for a Regulatory Affairs Specialist to join our team at SINGAFUTURE PTE. LDT.About the RoleThe Regulatory Affairs Specialist will be responsible for developing, implementing, and reviewing compliance policies, procedures, and internal controls to ensure adherence to regulatory obligations.Key Responsibilities:Develop Compliance Policies:...


  • Singapore INTERNATIONAL FLAVORS & FRAGRANCES (GREATER ASIA) PTE. LTD. Full time

    Roles & ResponsibilitiesThis position will be responsible for the management of product registrations, product compliance or product safety and risk assessment for Animal Nutrition & Health. IFF applies expert science to advance market-driven, healthy, and sustainable solutions for the food/feed, beverage, dietary supplements, and many other industries. The...


  • Central Singapore Emprego SG Full time

    **Location** - Singapore, Central Singapore**Job Type** - Full Time**Salary** - $3,500 - $5,500 Per Month**Date Posted** - 1 hour agoAdditional Details **Job ID** - 103882**Job Views** - 1Roles & Responsibilities **Job Title: Regulatory Affairs Specialist, Chemicals** **Reports to: Sr Manager, Business Process Excellence** **Location: Marsiling,...


  • Singapore RESPIREE PTE. LTD. Full time

    We are looking for a Regulatory and Quality Affairs Specialist to join our team at RESPIREE PTE. LTD. As a key member of our organization, you will play a crucial role in ensuring that our products meet the highest standards of quality and regulatory compliance.ResponsibilitiesDevelop and maintain quality management systems (QMS) that align with...


  • Singapore HAYS SPECIALIST RECRUITMENT PTE. LTD. Full time

    Roles & ResponsibilitiesYour new company Our client is a fast growing food and beverages company, with a strong presence across Asia. They are looking for an experienced Regulatory Affairs Lead to help them grow their regulatory team here in Singapore.Your new roleBelow are some of the key responsibilities for the role;· Develop and implement regulatory...


  • Singapore MSD Full time

    **Specialist, Regulatory Affairs** **THE OPPORTUNITY** - Based in Singapore, top-ranked biopharmaceutical company on The Straits Times and Statista’s list of Best Employers in Singapore for two consecutive years (2020, 2021). - Join the premier biopharmaceutical company that has been in Singapore for more than 25 years and in AP for over 60 years. Our...


  • Singapore Andaman Medical Full time

    We are looking for a Regulatory Affairs Specialist with at least 1 year experience in medical devices and or any related field, who can further assist our team in Thailand in processing medical device registration, determining risk classifications of health products and monitoring trends regarding the industry regulations. - Preparing and submitting...


  • Singapore MASON & CO PTE. LTD. Full time

    The company I’m representing is a leading consumer healthcare MNC with a good presence globally. They are looking for a Regulatory Affairs Specialist to help with their product registrations across the ASEAN region. This incumbent would have opportunities for career progression internally. **Responsibilities**: - To prepare and track overall regulatory...


  • Singapore DADACONSULTANTS PTE. LTD. Full time

    The Regulatory Affairs Specialist will be responsible for providing legal and compliance advice to senior management on relevant regulatory and operational matters.ResponsibilitiesMonitor and manage legal and compliance risks across all business processes and support decision-making with risk assessments.Draft, review, and negotiate a wide range of legal...


  • Singapore BLUE EDGE ADVISORS PTE. LTD. Full time

    About Blue Edge AdvisorsWe are a leading financial services firm seeking an experienced Regulatory Affairs Specialist to join our team.This critical role supports the firm's regulatory obligations, ensuring enterprise-wide compliance with MAS and NFA guidelines.Job Summary:The successful candidate will be responsible for developing and maintaining compliance...

  • Regulatory Affairs

    3 days ago


    West Singapore Emprego SG Full time

    **Location** - Singapore, West**Job Type** - Permanent**Salary** - $3,500 - $8,000 Per Month**Date Posted** - 59 minutes agoAdditional Details **Job ID** - 97191**Job Views** - 6Roles & Responsibilities We are a global leader in the manufacturing of medical devices and delivering solutions to improve lives through today’s technology and future...


  • Singapore PERFORMANCE LABS PTE. LTD. Full time

    We are seeking a Regulatory Affairs Assocaite to work with our US corporate office. Excellent opportunity for a hard-working, creative, and detail-oriented person with an interest in developing a career working with countries around the world at a dynamic company filled with energetic and committed colleagues supporting innovative nutritional and personal...


  • Singapore Johnson & Johnson Full time

    *** The Regulatory Affairs Specialist has the responsibility to Supports regulatory department to ensure efficient and compliant business processes and environment. Assists in the registration of new products/changes/renewal licenses by preparing documentation needed for registration submissions in Singapore, Malaysia and rest of ASEAN countries. Adheres...

  • Regulatory Affairs

    4 days ago


    Singapore RESPIREE PTE. LTD. Full time

    Roles & ResponsibilitiesRegulatory Affairs and Quality Assurance InternWe're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.We are looking for an intern who can begin in Apr/May 2025, and can commit for at least 3 months.Key Responsibilities- Maintain and update regulatory documentation...

  • Regulatory Affairs

    2 days ago


    Singapore RESPIREE PTE. LTD. Full time

    Roles & ResponsibilitiesRegulatory Affairs and Quality Assurance InternWe're seeking a detail-oriented and organized individual to support our Regulatory Affairs and Quality Assurance (RAQA) team.We are looking for an intern who can begin in Apr/May 2025, and can commit for at least 3 months.Key Responsibilities- Maintain and update regulatory documentation...


  • Singapore Novo Nordisk Full time

    Regulatory Affairs and Pharmacovigilance Specialist **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Singapore, Singapore, SG **About the department** Novo Nordisk Singapore supports both Singapore and Brunei. Our team is dedicated to ensuring regulatory compliance for new products and product amendments, thereby maintaining our license to...