
Senior Quality Assurance and Regulatory Affairs Manager
4 days ago
We are seeking an experienced and skilled Medical Device Regulatory Affairs Specialist to join our esteemed client in the medical device industry. As a key member of the regulatory team, you will play a vital role in ensuring compliance with relevant regulations and guidelines.
The ideal candidate will have strong knowledge of quality systems and regulatory frameworks for medical devices, including ISO 13485, MDD, MDR, GMP, and GDP. They should also possess hands-on experience with regulatory submissions, post-market surveillance, and risk management.
About the Role:
- Ensure compliance with regulatory requirements and industry standards.
- Coordinate with regulatory authorities for obtaining required permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
- Manage regulatory submissions and ensure timely approvals.
- Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Requirements:
- Strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
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