Asia Pacific Regulatory Specialist
7 days ago
Accuray Asia Ltd is seeking a skilled Regulatory Affairs Specialist to support the Asia Pacific team in obtaining medical device pre-market regulatory approvals. This role involves preparing and submitting regulatory applications, managing technical files, and collaborating with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific.
The ideal candidate will have a strong understanding of Asia Pacific regulations and standards applicable to medical devices, as well as experience in clearing medical devices to market in countries such as Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong. Proficiency in working through third parties to obtain market clearance is also essential.
- Main Responsibilities
- Prepare and submit regulatory applications for medical device market approvals in Asia Pacific Region
- Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System
- Collaborate with cross-functional teams to ensure market access for Accuray products and services in Asia Pacific
Requirements
- Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry
- Minimum of 3 years' Regulatory Affairs experience 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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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist, AP Region to support the obtaining of medical device pre-market regulatory approvals and ensure market access for Accuray products and services in Asia Pacific.This role involves authoring regulatory submissions through third-party entities and monitoring developing standards and...
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Hong Kong, Central and Western District, Hong Kong SAR China Accuray Asia Ltd Full timeJob DescriptionWe are seeking a skilled Regulatory Affairs Specialist to support the obtainment of medical device pre-market regulatory approvals for Accuray products and services in Asia Pacific.The ideal candidate will author regulatory submissions in Asia Pacific through third-party entities and ensure vigilance regarding developing standards and...
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