Medical Device Clearance Specialist
6 days ago
This is an exciting opportunity for a motivated Regulatory Affairs Specialist to join our team at Accuray Asia Ltd. As a key member of the Regulatory and Quality team, you will play a critical role in ensuring compliance with Asia Pacific regulations and standards for medical devices.
Responsibilities
- Support obtaining medical device pre-market regulatory approvals in Asia Pacific.
- Collaborate with internal stakeholders to ensure compliance with regulatory requirements.
- Participate 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.
- Excellent verbal and written English and Chinese communication skills.
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