Asia Pacific Medical Device Regulatory Compliance Expert
2 weeks ago
About the Role
The ideal candidate will have a Bachelor's Degree in a technical discipline and at least 3 years' experience in Regulatory Affairs for medical devices. They must have solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
They should possess a proven track record clearing medical devices to market in Asia Pacific countries, including but not limited to Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong. Proficiency in working through third parties to obtain market clearance in these countries is also essential.
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 for medical devices, especially products containing software and electro/mechanical components.
- Solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
- Proven track record clearing medical devices to market in Asia Pacific countries, including but not limited to Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
- Proficiency in working through third parties to obtain market clearance in Asia Pacific countries.
- Excellent verbal and written English and Chinese communication skills; strong attention to detail and excellent organizational skills.
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