Specialist - Regulatory Affairs - Medical Devices

- We are seeking an experienced Regulatory Affairs Specialist to oversee regulatory. compliance for medical devices, combination products, and procedure packs.

- The ideal candidate will have expertise in global regulatory submissions, compliance with international standards, and project management.

- Manage regulatory submissions for medical devices and in-vitro medical devices.

- Lead regulatory projects, ensuring coordination with internal teams, notified bodies, and regulatory authorities.

- Prepare applications for new medical device licenses, post-approval changes, and timely renewals in compliance with EU-MDR/IVDR, IMDR, HSA, and ASEAN Medical Device Directives.

- Ensure compliance with international standards such as ISO 13485, ISO 14971, ISO10993, IEC 62366, IEC 62304, ISO 15223, ISO 20417, and ISO 60601.

- Apply for NCC, MSC, and FSC for both manufactured and imported products.

- Support the tender team in bid submissions and GEM Portal processes.

- Handle regulatory activities related to export and post-approval changes.