
Senior Regulatory Affairs Professional
3 days ago
We are seeking an experienced Medical Device Compliance Specialist to join our esteemed client in the medical device industry.
- Key Responsibilities:
- Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS standards.
- Coordinate with regulatory authorities for obtaining required 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.
- Required Skills:
- 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.
- Benefits:
- Opportunity to work with a leading medical device company.
- Collaborative team environment.
- Professional development and growth opportunities.
- How to Apply:
- Send your resume and cover letter to [insert contact information].
-
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