APAC Regulatory Affairs and Quality Manager
6 days ago
Accuray Asia Ltd is a leading medical technology company that specializes in radiation oncology solutions. We are seeking a skilled Regulatory Affairs Specialist to join our team and support the successful market access of our medical devices in Asia Pacific.
The ideal candidate will have a strong understanding of the regulatory landscape in Asia Pacific and be able to navigate the complex requirements for obtaining pre-market approvals.
About the Role:
- Support the development and implementation of regulatory strategies for Asia Pacific markets.
- Collaborate with internal stakeholders to ensure compliance with regulatory requirements.
- Develop and maintain relationships with regulatory agencies and industry partners.
Key Responsibilities:
- Develop and implement regulatory plans for Asia Pacific markets.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
- Communicate effectively with regulatory agencies and industry partners.
Requirements:
- 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.
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