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Asia Pacific Regulatory Compliance Specialist
1 week ago
The Regulatory Affairs Specialist will play a crucial role in ensuring market access for Accuray products and services in Asia Pacific. This position involves supporting the Director of Accuray Regulatory and Quality, Asia Pacific Region, in managing post-market agency reporting activities and handling recalls.
Key Accountabilities
- Author regulatory submissions in Asia Pacific through third-party entities.
- Handle post-market agency reporting activities, including Recall and Correction & Removal Reporting.
- Collaborate with engineering design control teams to ensure new product introductions comply with regulatory requirements.
Qualifications
- Qualified applicants must have a Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum 3 years' Regulatory Affairs experience in medical devices, especially products containing software and electro/mechanical components.
- Proven track record clearing medical devices to market in Asia Pacific countries, including Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
