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Quality Assurance and Regulatory Affairs Specialist
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Medical Device Quality Assurance and Regulatory Affairs Manager
Job Overview:We are seeking a seasoned professional to lead our Medical Device Quality Assurance and Regulatory Affairs team. The ideal candidate will have extensive experience in quality systems, regulatory frameworks, and medical device compliance.
Key Responsibilities:
- Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
- Coordinate with regulatory authorities to obtain necessary permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance for Class Is, II, and III medical devices.
- Manage regulatory submissions and ensure timely approvals.
- Handle Corrective and Preventive Actions to maintain compliance and drive continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Profile:
- Proven understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, post-market surveillance, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
A competitive compensation package, comprehensive benefits, and opportunities for growth and development.