
Medical Device Compliance Specialist
2 days ago
We are seeking a seasoned Quality Assurance and Regulatory Affairs professional to join our esteemed client in the Medical Device Industry.
This key position involves ensuring compliance with regulatory requirements, overseeing risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices. The ideal candidate will possess strong understanding of quality systems and regulatory frameworks for medical devices.
- Main Responsibilities:
- Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
- Coordinate with local FDA and CDSCO for obtaining necessary permissions and approvals.
- Manage regulatory submissions and guarantee timely approvals.
- Implement Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
- Key Qualifications:
- 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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