
Senior Quality Assurance Specialist
4 days ago
We are seeking a highly skilled professional with expertise in quality systems and regulatory frameworks for medical devices.
The ideal candidate will possess hands-on experience in regulatory submissions, post-market surveillance, and risk management. Additionally, they should be able to oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices, while managing regulatory submissions and ensuring timely approvals.
Candidate Profile:
- Strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, post-market surveillance, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
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