Senior Medical Device Quality Leader
2 weeks ago
We are seeking a seasoned quality professional to lead our client's Quality Assurance and Regulatory Affairs efforts in the Medical Device Industry.
Key Responsibilities:
- Compliance and Risk Management
- Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
- Regulatory Submissions and Approvals
- Manage regulatory submissions and ensure timely approvals.
- Coordinate with local FDA and CDSCO for obtaining required permissions and approvals.
- Corrective and Preventive Actions
- Handle CAPA to maintain compliance and continuous improvement.
- Audits and Inspections
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
Candidate Profile:
- 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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