Lead Quality Assurance and Regulatory Affairs Specialist
3 days ago
We are seeking a seasoned professional to lead quality assurance and regulatory affairs efforts in the Medical Device Industry.
Key responsibilities include ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
The ideal candidate will have relevant experience in quality systems and regulatory frameworks for medical devices.
- Ensure compliance with industry regulations.
- Coordinate risk management and clinical evaluation processes.
- Oversee submissions and approvals for Class I, II, and III medical devices.
- Manage Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
Required skills and qualifications:
- Strong understanding of quality systems and regulatory frameworks.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
Candidate profile:
- Strong communication, documentation, and coordination skills.
- Ability to manage multiple projects and priorities.
- Excellent problem-solving and analytical skills.
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