Asia Pacific Medical Device Compliance Expert
19 hours ago
This position requires a highly skilled Regulatory Affairs professional to support the preparation and submission of regulatory applications for product market approvals in the Asia Pacific Region.
The ideal candidate will have a deep understanding of Asia Pacific regulations and standards applicable to medical device market clearance, as well as experience in managing Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
Key Responsibilities:
- Manage the preparation and submission of regulatory applications required for product market approvals in the Asia Pacific Region.
- Ensure the Asia Pacific Technical Files are managed in compliance with local regulatory requirements and the Accuray Quality Management System.
- Provide Regulatory Affairs expertise on new product introduction and engineering design control teams.
- Work closely with research personnel, application specialists, and risk management specialists to guarantee clinical research and clinical evaluations align with necessary regulatory requirements.
- Participate in quality system and design dossier audits.
- Prepare materials to facilitate Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc. decision-making processes.
- Coordinate with Regulatory Agencies regarding recall activities.
- Prepare documentation and reports after interpreting Asia Pacific countries' regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
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, specifically in medical devices with software and electro/mechanical components.
- Strong knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
- A proven track record clearing medical devices to market in Asia Pacific countries, including Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
- Proficiency in working through third-party entities to achieve market clearance in Asia Pacific countries.
- Excellent verbal and written English and Chinese (Mandarin) communication skills; strong attention to detail and excellent organizational skills.
- Experience in project management is preferred.
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