Senior Global Clinical & Regulatory Strategist

Advanced Biomedical Instrumentation Centre ABIC; Hong Kong; On-site; HKD 1,000,000 - 1,500,000; Full time

Job summary

Advanced Biomedical Instrumentation Centre ABIC in Hong Kong seeks a Senior Clinical & Regulatory Affairs Specialist to lead regulatory strategy and oversight for medical devices, drugs, and software across global markets. You will manage IITs and sponsored trials, coordinate with IRBs, CDMOs, and CROs, and drive regulatory submissions.

The role requires a PhD in Life Sciences, 5+ years in pre-clinical/clinical operations, and strong English/Putonghua communication.

Qualifications

• PhD in Healthcare, Life Sciences, or related discipline (world’s top 100 subject ranking).
• 5+ years in pre-clinical operations and clinical studies with regulatory approvals (FDA, NMPA, EMA, PMDA).
• Strong knowledge of regulatory processes for medical devices/biologics across key markets.
• Excellent presentation skills for investors and partners.

Responsibilities

• Study biomedical technologies and regulatory strategies across major markets.
• Draft, explain, negotiate, and deliver regulatory plans to stakeholders.
• Lead relationships with regulatory officers, medical professionals, and investors.

Skills

Regulatory affairs

Clinical studies

Investor presentations

Networking

Bilingual English/Putonghua

Dossier writing

Project management

Negotiation

Education

PhD in Healthcare/Life Sciences

Job description

Advanced Biomedical Instrumentation Centre ABIC in Hong Kong seeks a Senior Clinical & Regulatory Affairs Specialist to lead regulatory strategy and oversight for medical devices, drugs, and software across global markets. You will manage IITs and sponsored trials, coordinate with IRBs, CDMOs, and CROs, and drive regulatory submissions.

The role requires a PhD in Life Sciences, 5+ years in pre-clinical/clinical operations, and strong English/Putonghua communication.