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Medical Device Regulatory Affairs Expert
2 weeks ago
We are seeking a seasoned professional to fill the role of Executive Quality Assurance Regulatory Affairs in the Medical Device Industry.
- Ensure adherence to ISO 13485, MDD, and QMS standards.
- Coordinate with regulatory authorities for required permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
- Manage regulatory submissions and ensure timely approvals.
- Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
- Support audits and inspections to ensure readiness for regulatory authority reviews.
- 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 standards.
- Strong communication, documentation, and coordination skills.
Candidates will have the opportunity to work in a dynamic environment and contribute to the success of our organization.
About the RoleThis is an exciting opportunity for a motivated individual to join our team and make a meaningful impact.
