Regulatory Affairs Specialist, Asean

7 days ago


Singapore INTEGRITY PARTNERS PTE. LTD. Full time

Medical Device MNC leading technological innovations specialising in Orthopaedics
- Competitive renumeration
- Regional responsibilities

**JOB DESCRIPTION**

The successful incumbent will be responsible for the daily regulatory affairs operations including regulatory submissions and ensuring the compliance of regulatory affairs matters affecting the company’s operations and products.
- Prepare and submit regulatory documents of products for the ASEAN markets, supporting distributors and the company’s affiliates.
- Liaising with relevant regulatory authorities on submission projects if necessary
- RA planning for ASEAN markets, and supporting APAC level projects when needed
- Review product labelling and directions for use (if translation is required)
- RA compliance and document control, maintaining and updating product registration and listing databases for assigned countries
- Collect and assess product change information to take necessary actions, including regulatory submissions
- Regulatory intelligence
- Recall and complaint support, FSCA, post-market surveillance
- Participate in Quality System Audits (Internal/External)

**Requirements**:

- Relevant Bachelor’s Degree (e.g. Science, Engineering)
- At least 2 - 4 year of Medical Device RA experience
- Strong knowledge and understanding of ASEAN regulations
- Excellent interpersonal skills - Internal and external stakeholders management
- Ability to prioritize and to work in a fast-paced environment handling multiple tasks/requests
- Proactive, independent, and a great team player
- Resourceful and inquisitive, able to comprehend technical/engineering/medical terminology or able to reference literature for better understanding

Principal Consultant: Cheong Yee Yin

Registration Number: R22108633

EA License Number: 17C8502



  • Singapore ALCOTECH PTE. LTD. Full time

    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. Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...


  • Singapore ALCOTECH PTE. LTD. Full time

    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.Role Overview We are seeking a Regulatory Affairs Specialist with either experience working at the Health Sciences...


  • Singapore ALCOTECH PTE. LTD. Full time

    **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. **Role Overview**: **Key Responsibilities**: - Prepare, review, and submit medical device registration dossiers...


  • 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 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 beBeeRegulatory Full time

    We are seeking an experienced Regulatory Affairs Specialist to manage medical device registrations and ensure compliance with regulations in Singapore and ASEAN markets.


  • 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

    The Regulatory Affairs Specialist (MD) is a member of the local Regulatory Affairs department, responsible for activities to support and actively contributing to the regulatory compliance of medical devices products under their responsibility. - The Regulatory Affairs Specialist (MD) will be a member of the local regulatory affairs department within Johnson...


  • 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...


  • Singapore INTEGRITY PARTNERS PTE. LTD. Full time

    **THE OPPORTUNITY**: An esteemed **Medical Devices Company **is currently seeking a highly capable **Regulatory Affairs Specialist **to join their team. The successful incumbent will be tasked with the development and implementation of efficient regulatory strategies and processes, ensuring timely product registration, life cycle management, and post-market...