
Senior Regulatory Affairs Specialist
1 day ago
We are looking for a talented professional to join our esteemed organization in the Medical Device Industry. This is an exciting opportunity for someone with experience in quality assurance and regulatory affairs.
Job DescriptionThe ideal candidate will have a strong understanding of quality systems, regulatory frameworks, and medical device regulations. Key responsibilities include ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements, coordinating with local authorities for obtaining required permissions and approvals, overseeing risk management, clinical evaluation, and post-market surveillance, and managing regulatory submissions to ensure timely approvals.
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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