Senior Regulatory Specialist

About the role

The Senior Regulatory Specialist will lead regulatory support for new product introductions and sustaining activities across APAC markets, ensuring compliance and market access. This hybrid position requires close collaboration with regional teams, distributors, and in‑country representatives.

Key responsibilities

• Lead regulatory support for New Product Introduction (NPI) and sustaining activities in Hong Kong, Singapore, Macau, and Taiwan.
• Prepare, compile, review and submit regulatory dossiers, registrations, renewals, amendments and notifications.
• Assess regulatory impact of product, labeling, manufacturing, supplier, specification and design changes.
• Maintain product registrations and licenses throughout the product lifecycle.
• Monitor regulatory commitments, submission timelines, approval status and renewal requirements.
• Support post‑market activities such as field actions, vigilance submissions and compliance requests.

Required profile

• Bachelor's or Master's degree in Engineering, Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs or related discipline.
• 5–7 years of experience in Regulatory Affairs within medical devices, healthcare or life sciences, with at least 3 years in APAC market registrations.
• Proven ability to manage multiple projects independently and deliver high‑quality regulatory outputs.

Required skills

• Experience with regulatory information management systems, PLM systems and document control tools.
• Working knowledge of regulatory requirements for Hong Kong, Singapore, Macau and Taiwan.
• Familiarity with technical documentation, design control, change control and product lifecycle management processes.