Executive Quality Assurance and Regulatory Affairs Specialist
2 days ago
We are seeking a highly skilled Executive Quality Assurance and Regulatory Affairs Specialist to join our team. This is an exciting opportunity for a professional with experience in quality systems and regulatory frameworks for medical devices.
The ideal candidate will have strong understanding of quality management systems, regulatory requirements, and industry standards. They will be responsible for ensuring compliance with relevant regulations, coordinating with regulatory authorities, and managing risk assessment and mitigation strategies.
Key Responsibilities:
- Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Coordinate with local FDA and CDSCO for obtaining required permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) 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, inspections, and ensure readiness for regulatory authority reviews.
Required Skills and Qualifications:
- 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 of this role include the opportunity to work on complex projects, collaborate with cross-functional teams, and develop your skills in quality assurance and regulatory affairs.
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