Senior Regulatory Affairs Specialist, AP Region
5 days ago
We are seeking a Senior Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role involves authoring regulatory submissions through third-party entities and ensuring market access for Accuray products.
Key Responsibilities
- Prepare and submit regulatory applications required for product market approvals in the Asia Pacific region.
- Manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
- Function as a subject matter expert on new product introduction and engineering design control teams.
Requirements
- A Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- A minimum of 3 years' experience in Regulatory Affairs for medical devices, especially those containing software and electro/mechanical components.
- Solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
- Excellent verbal and written English and Chinese (Mandarin) communication skills.
About Accuray Asia Ltd
Accuray Asia Ltd is a leading manufacturer of medical devices that require regulatory approvals in the Asia Pacific region. We offer a competitive salary and benefits package to successful candidates who can join our team as a Senior Regulatory Affairs Specialist.
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