Senior Regulatory Affairs Specialist

About the role

Roche Diagnostics is seeking a Senior Regulatory Affairs Specialist to act as a strategic partner for commercial and operational teams, driving regulatory market access and registration excellence across Hong Kong and Macau.

Key responsibilities

• Develop and execute regulatory strategies to secure product registrations, approvals, and lifecycle maintenance in Hong Kong, Macau and related markets.
• Monitor regulatory changes, maintain proactive dialogue with health authorities and industry associations, and influence policy frameworks.
• Lead regulatory submissions for designated product portfolios, providing guidance to resolve complex compliance challenges.
• Ensure local operations comply with global quality standards, IVD/medical device regulations, and internal SOPs, including audit readiness and promotional material reviews.
• Collaborate with commercial, marketing, quality, regional and global stakeholders to align regulatory activities throughout the product lifecycle.

Required profile

• B.S. degree in Biomedical Science, Life Sciences or a related field.
• 4‑5 years of health‑related regulatory experience, preferably with team management exposure.
• Strong understanding of regulatory requirements in HK, Macau, China, EU and US authorities.
• Strategic thinker with ability to simplify complex regulatory issues and challenge the status quo.

Required skills

• In‑depth knowledge of Medical Device and IVD regulations and international quality standards (e.g., ISO).
• Excellent cross‑functional communication to translate regulatory requirements into commercial solutions.
• Proficiency with digital tools and automation for tracking systems and dashboards.
• Ability to advocate externally, shape policy and simplify regulatory matters.