Regulatory Affairs Specialist, AP Region Lead
6 days ago
Accuray Asia Ltd is seeking a highly skilled Regulatory Affairs Specialist to support the successful market access of our medical devices in Asia Pacific.
The ideal candidate will have a solid understanding of the regulatory landscape in Asia Pacific and be able to navigate the complex requirements for obtaining pre-market approvals.
About the Role:
- Author and manage regulatory submissions in Asia Pacific through third-party entities.
- Vigilantly monitor developing standards and regulations and their impact on Accuray product clearances.
- Handle post-market agency reporting activities such as Recall and Correction & Removal Reporting.
Key Responsibilities:
- Prepare and submit regulatory applications required for product market approvals in Asia Pacific.
- 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 are performed in accordance with necessary regulatory requirements.
Required Qualifications:
- Bachelor's Degree in a technical discipline such as Engineering, Bio-medical Engineering, Computer Science, Physics, Biology, or Chemistry.
- Minimum of 3 years' experience in Regulatory Affairs for 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.
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