Medical Device Regulatory Specialist
3 days ago
We are seeking a skilled Medical Device Regulatory Specialist to join our team at Accuray Asia Ltd. The ideal candidate will have a solid background in regulatory affairs, with experience in medical devices and software/electro/mechanical components.
The successful candidate will support the preparation and submission of regulatory applications for product market approvals in the Asia Pacific Region. This includes preparing and managing Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
Key Responsibilities:
- Prepare and submit regulatory applications required for product market approvals in the Asia Pacific Region.
- Prepare and manage Asia Pacific Technical Files in compliance with local regulatory requirements and the Accuray Quality Management System.
- Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams.
- Assist research personnel, application specialists, and risk management specialists to ensure clinical research and clinical evaluations are performed in accordance with necessary regulatory requirements.
- Participate as a subject matter expert in internal and external quality system and design dossier audits.
- Gather and prepare materials to enable Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc. decision-making process.
- Collate and prepare all materials, reports, and follow-up with Regulatory Agencies regarding recall activity.
- May prepare documentation and reports after interpreting Asia Pacific countries regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
Qualifications:
- 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' Regulatory Affairs experience in medical devices, especially products containing software and electro/mechanical components.
- Solid working knowledge and experience of the 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 but not limited to Korea, Singapore, Malaysia, Thailand, Australia, Taiwan, and Hong Kong.
- Proficiency in working through third parties to obtain 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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