Regulatory Affairs Expert, Asia Pacific
3 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals in Asia Pacific. The ideal candidate will have experience authoring regulatory submissions through third-party entities and be vigilant of developing standards and regulations impacting Accuray product clearances.
Key Responsibilities
- Prepare, submit, and manage regulatory applications for product market approvals in Asia Pacific Region.
- Collaborate with research personnel, application specialists, and risk management specialists to ensure clinical research and evaluations meet necessary regulatory requirements.
- Participate as a subject matter expert in internal and external quality system audits.
Requirements
- 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.
- Solid working knowledge of Asia Pacific regulations and standards applicable to medical device market clearance.
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