Urgent! Regulatory Affairs Manager (Medical Devices) Job Opening In Hong Kong, Hong Kong – Now Hiring Centre for Cerebro-cardiovascular Health Engineering
About the Research Centre
In collaboration with CityU, University of Oxford, and Karolinska Institutet, the Hong Kong Centre for Cerebro-cardiovascular Health Engineering (COCHE) was established with the support of the ITC-InnoHK Programme to develop new ways to tackle cardiovascular disease (CVD), which is the world's leading cause of morbidity and mortality.
To address the most pressing health challenges caused by CVD, COCHE focuses on developing innovative technologies such as flexible and wearable devices, biomedical and molecular imaging, nano-biosensing, micro-robotics, healthcare AI systems, and other ground-breaking methods to enable early prevention, diagnosis, and intervention of the disease.
These technologies can reduce human costs while alleviating financial and social burdens on the healthcare system.
For more information on COCHE, please visit:
Job Description
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)
Preferred Hiring Qualifications:
Remuneration & Duration of Appointment
The remuneration package will be highly competitive, and commensurate with qualifications and experience.
Fringe benefits for full-time appointments include leave and medical insurance, etc.
Initial appointments will be made on a fixed-term contract.
The possibility of re-appointment after the initial contract period will be based on performance evaluation and mutual agreements.
The application Materials that Should be Included
Application Closing Date:
The post is immediately available.
Consideration of applications will be open until the position is filled.
Additional Information/links:
Application Procedures:
Please apply below or email your CV, cover letter including your current and expected salary and relevant documents supporting your qualifications to by specifying the job advertisement no.
RAM.
Only shortlisted candidates will be contacted.
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Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide
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Great news! Centre for Cerebro-cardiovascular Health Engineering is currently hiring and seeking a Regulatory Affairs Manager (Medical Devices) to join their team. Feel free to download the job details.
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