Senior Clinical & Regulatory Affairs Leader

Advanced Biomedical Instrumentation Centre ABIC; Hong Kong; Sur place; HKD 900 000 - 1 800 000; Plein temps

Résumé du poste

Advanced Biomedical Instrumentation Centre ABIC seeks a Senior Clinical & Regulatory Affairs Specialist to oversee regulatory strategies for medical devices, drugs, and software, including AI tools and data science applications. You will lead pre-clinical and clinical development, draft regulatory documents, and coordinate with IRBs, CROs, and manufacturing partners.

The role requires experience with FDA, NMPA, EMA, PMDA, and other bodies, plus strong English and Putonghua communication, and

Qualifications

• PhD degree in Healthcare, Life Sciences, or a related discipline.
• At least 5 years of experience in running pre-clinical operations and clinical studies with regulatory approvals.
• Deep knowledge of regulatory requirements for medical devices and biologics across major markets.
• Ability to deliver presentations to investors and business partners.
• Excellent English and Putonghua; strong bilingual writing in Chinese and English.
• Proven experience in writing, submitting, and managing regulatory dossiers.

Responsabilités

• Study biomedical technologies and products and investigate approval strategies with regulatory bodies.
• Develop plans for obtaining regulatory approvals from pre-clinical to clinical stages.
• Draft and deliver regulatory plans to investors, regulators, CROs, and partners.
• Act as primary contact for regulatory officers, clinicians, investors, and project teams.
• Manage budgets, milestones, and vendor contracts to ensure on-time delivery.
• Recruit clinical doctors, hospitals, and groups for studies and secure participation.
• Support IITs and sponsored trials, including pre-clinical operations and documentation.
• Lead documentation like protocols, consent forms, and IRB submissions.
• Travel frequently to Mainland China and overseas as required.

Description du poste

Advanced Biomedical Instrumentation Centre ABIC seeks a Senior Clinical & Regulatory Affairs Specialist to oversee regulatory strategies for medical devices, drugs, and software, including AI tools and data science applications. You will lead pre-clinical and clinical development, draft regulatory documents, and coordinate with IRBs, CROs, and manufacturing partners.

The role requires experience with FDA, NMPA, EMA, PMDA, and other bodies, plus strong English and Putonghua communication, and