Regulatory Affairs Manager (Medical Devices)

We are seeking a highly skilled professional with a medical background to coordinate and manage multi-center clinical trials, ensuring compliance with ICH-GCP and Hong Kong/Mainland regulations. This role requires regular travel between Hong Kong and Mainland China to oversee trial execution and stakeholder collaboration.

Responsibilities:
1. Regulatory Strategy & Submissions
• Lead NMPA registration processes for medical devices, including product classification, technical documentation preparation (e.g., risk assessment, clinical evaluation reports), and coordination with testing laboratories
• Manage overseas regulatory registrations (FDA, CE, UKCA), ensuring compliance with regional requirements (e.g., FDA 510(k)/PMA, EU MDR/IVDR, UKCA technical files)
• Collaborate with R&D, QA/QC, and manufacturing teams to align product development with regulatory standards

2. Quality & Compliance Oversight
• Ensure adherence to ISO 13485 and GMP standards across product lifecycle, including design controls, production processes, and post-market surveillance
• Conduct internal audits and support external audits by regulatory bodies (e.g., NMPA, FDA, Notified Bodies)

3. Regulatory Intelligence & Training
• Monitor updates in global regulations (NMPA, FDA, EU, UK) and communicate impacts to internal stakeholders
• Develop training programs for cross-functional teams on regulatory requirements and compliance

4. Cross-functional Collaboration
• Liaise with external partners, including CROs, testing agencies, and regulatory consultants, to expedite approvals
• Support international market expansion by addressing regional regulatory barriers

General Qualification

Education:
Bachelor’s degree or higher in Life Sciences, Biomedical Engineering, or related fields. Advanced degrees (e.g., MSc, PhD) preferred.

Experience:
5+ years in medical device regulatory affairs with proven success in NMPA registrations and at least 2 FDA/CE/UK approvals;
In-depth knowledge of ISO 13485, GMP, and quality system standards;

Skills:
Proficiency in technical documentation (e.g., design dossiers, clinical evaluation plans)
Strong project management and communication skills for global regulatory coordination.

Language:
Fluency in English and Mandarin (written and spoken) to liaise with global teams and authorities

Preferred Qualifications:
Experience with software-as-a-medical-device (SaMD) or AI-driven medical technologies
Certification in regulatory affairs (e.g., RAC, CE Marking expertise)

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