Medical Device Regulatory Specialist
2 weeks ago
We are seeking a skilled Medical Device Regulatory Specialist to join our team at Accuray Asia Ltd. As a key member of our regulatory affairs team, you will play a crucial role in ensuring the successful market access of our medical devices in the Asia Pacific region.
Key Responsibilities:
- Prepare and submit 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 our quality management system.
- Function as a 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.
Requirements:
- A Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum 3 years' experience in Regulatory Affairs in medical devices, especially products containing software and electro/mechanical components.
- Solid working knowledge and experience of Asia Pacific regulations and standards applicable to medical device market clearance.
- 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.
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