Regulatory Affairs Specialist, Asia Pacific Region
3 days ago
Job Description
We are seeking a highly skilled Regulatory Affairs Specialist to support obtaining medical device pre-market regulatory approvals in the Asia Pacific region. This role will ensure market access for Accuray products and services in the area.
The ideal candidate will author regulatory submissions through third-party entities and stay vigilant of developing standards and regulations impacting Accuray product clearances. Additionally, this position will handle post-market agency reporting activities, including Recall and Correction & Removal Reporting.
Key Responsibilities
- Prepare, submit, and manage regulatory applications required for product market approvals in the Asia Pacific Region.
- Author 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.
- Collaborate with research personnel, application specialists, and risk management specialists to ensure clinical research and clinical evaluations align with necessary regulatory requirements.
- Participate as a subject matter expert in internal and external quality system and design dossier audits.
- Gather and prepare materials for decision-making processes related to Medical Device Reports (MDR), Vigilance, Adverse Events, Recall, etc.
- Compile and prepare all materials, reports, and follow-up with Regulatory Agencies regarding recall activity.
- 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 within the medical devices industry, particularly with 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 communication skills in English and Chinese (Mandarin); strong attention to detail and excellent organizational skills.
- Experience in project management is preferred.
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