Medical Device Product Approval Specialist for APAC
6 days ago
We are seeking a talented Regulatory Affairs Specialist to join our team in Hong Kong.
The ideal candidate will have experience with Asia Pacific regulations and standards applicable to medical device market clearance, as well as proficiency in working through third parties to obtain market clearance in the region.
This position offers a unique opportunity to contribute to the growth and success of our company while developing your skills and expertise in Regulatory Affairs.
Responsibilities and Requirements:- Prepare, submit, and manage regulatory applications required for product market approvals in Asia Pacific Region.
- Develop and maintain knowledge of Asia Pacific regulations and standards.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum of 3 years' experience in Regulatory Affairs in medical devices, especially products containing software and electro/mechanical components.
- Solid working knowledge and experience of the Asia Pacific regulations and standards applicable to medical device market clearance.
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