Part-time Regulatory Affairs Consultant - In Vitro Diagnostics (IVD)

Insighta Limited • Part Time • Hong Kong, Hong Kong, HK • 4w ago

Insighta Limited is seeking an experienced regulatory strategist to provide expect oversight and direction for IVD product registrations . This part-time consulting role is designed for a seasoned professional who will oversee the global regulatory landscape, including China, the EU and other international markets .

Key Responsibilities

Develop and implement comprehensive regulatory strategies for IVD products , targeting China (NMPA), EU (including EU MDR/IVDR), and other emerging overseas markets.
Oversee all registration processes across NMPA, CE-IVDR, and other regions, ensuring coherence and strategic alignment. Act as the point of escalation for critical regulatory decisions.
Monitor and interpret changing regulations (e.g., NMPA updates, IVDR transitional provisions). Assess business impact and advise leadership on mitigation strategies and policy shifts .
Partner with R&D, Clinical, and other teams to review product development plans and clinical evidence strategies to ensure they meet future regulatory requirements across multiple jurisdictions.
Provide strategic direction for Notified Body interactions , competent authority communications, and partner negotiations in overseas markets.
Advise on post-market surveillance, labeling/IFU strategy, and change management from a regulatory perspective, ensuring long-term compliance.

Required Qualifications

Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Biotechnology or related disciplines.
7+ years of regulatory affairs experience for IVD or medical device products , with demonstrated strategic leadership across multiple regions.
Strong knowledge of EU IVDR, NMPA regulations, ISO standards, and global regulatory requirements for medical devices.
Demonstrated experience developing regulatory strategy and lead multi-region submissions.
Excellent communication skills in English and Mandarin, Cantonese is a plus.
Collaborative, detail-oriented, organized, and able to prioritize competing deadlines.

Preferred Attributes

Experience advising on China Innovation Medical Device Special Review Applications is a strong advantage.
Experience in SEA or Middle East registration is a bonus.
Ability to review and critique regulatory dossiers for quality and completeness.
Project management skills and ability to coordinate cross-functional, cross-cultural teams.

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