Our client is large-scale company, developing advance technologies for medical use. They are now looking for high caliber candidate to join the team.
- Responsible for regulatory applications for the product market approvals in Asia Pacific.
- Handling pre-market regulatory issues for the products; and post-market activities afterwards.
- Ensure Asia Pacific Technical Files of products complies with the local regulatory and the Company's Quality Management System of the Asia Pacific regions.
- Responsible for regulatory issues on new product introduction and engineering design control teams.
- Ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements.
- Perform internal and external audits.
- Gather and prepare materials to enable Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
- Organize materials and reports for clients and agencies.
- Prepare different reports and documentation for clients, governmental regulatory agencies, etc.
- Support Post Market Surveillance activities i.e. Complaint Investigations, FSCA, MDR, etc.
- Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
- Solid working knowledge of the Asia Pacific regulations and standards applicable to medical device market clearance.
- Experience in handling medical device in Asia Pacific Region. (especially products containing software and electro / mechanical components)
- Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
- Good command in Cantonese, English and Mandarin; especially in English.
Interested parties, please click the “apply now” or send your updated resume with current and expected salary in MS word format to cv @headsearch21.com .
Ms. Nicole Yuen
Tel: 3188 3745
All information collected will be treated in strict confidence and be used for recruitment purpose only.
Company Web-Site: www.headsearch21.com
Hotline: (852) 3188 3586