
Quality Assurance and Regulatory Affairs Expert
6 days ago
We are seeking a seasoned Quality Assurance and Regulatory Affairs Expert to drive our Medical Device Industry operations forward.
Key Responsibilities:- Ensure seamless compliance with regulatory standards including ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Collaborate closely with local regulatory authorities for timely approvals and permissions.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) initiatives for Class I, II, and III medical devices.
- Manage regulatory submissions efficiently and ensure timely approvals.
- Develop and implement Corrective and Preventive Actions (CAPA) strategies to maintain compliance and foster continuous improvement.
- Provide support for audits, inspections, and ensure readiness for regulatory authority reviews.
The ideal candidate will possess in-depth knowledge of quality systems and regulatory frameworks for medical devices, hands-on experience with regulatory submissions, PMS, and risk management, as well as exceptional understanding of GMP, GDP, and ISO 13485 standards.
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