Regulatory Affairs Specialist
5 days ago
We are seeking a skilled Regulatory Affairs Specialist to support the obtaining of medical device pre-market regulatory approvals, ensuring market access for Accuray products and services in Asia Pacific. The ideal candidate will author regulatory submissions through third-party entities, be vigilant of developing standards and regulations, and handle post-market agency reporting activities.
Key Responsibilities:
- Prepare, submit, and manage regulatory applications for product market approvals in Asia Pacific.
- Author 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 comply with necessary regulatory requirements.
- Participate in internal and external quality system and design dossier audits as a subject matter expert.
- Gather and prepare materials for Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc., decision-making processes.
- Collate and prepare all materials, reports, and follow-up with Regulatory Agencies regarding recall activity.
The successful candidate must have 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, is required.
Solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance are essential.
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, is preferred.
Proficiency in working through third parties to obtain market clearance in Asia Pacific countries is required.
Excellent verbal and written English and Chinese communication skills, strong attention to detail, and excellent organizational skills are essential.
Experience in project management is an asset.
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