
Senior Medical Device Compliance Specialist
1 day ago
Medical Device Regulatory Expert
Job Overview:We are seeking a seasoned Medical Device Regulatory Expert to oversee compliance with stringent regulatory requirements.
Key Responsibilities:- Ensure strict adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
- Collaborate closely with regulatory authorities for obtaining necessary permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
- Manage regulatory submissions and ensure 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.
- Extensive knowledge of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Exceptional understanding of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
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