
Medical Device Compliance Specialist
5 days ago
This is a leadership role responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in the Medical Device Industry.
Key Responsibilities:- Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Coordinate with local authorities to obtain necessary permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for 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.
- Strong understanding of quality systems and regulatory frameworks.
- 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.
- 5-7 years of experience in the Medical Device Industry.
- B.Pharm/M.Pharm degree required.
- Relevant experience in Quality Assurance and Regulatory Affairs.
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