
Senior Quality Assurance and Regulatory Compliance Professional
21 hours ago
We are seeking a seasoned professional to assume a critical role within our Medical Device organization.
Key Responsibilities:
- Ensure adherence to ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements for Class I, II, and III medical devices.
- Coordinate with regulatory bodies to obtain necessary permits and approvals in a timely manner.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) initiatives to ensure compliance.
- Manage regulatory submissions and expedite approval processes.
- Implement Corrective and Preventive Actions (CAPA) to maintain quality standards and drive continuous improvement.
- Support audits, inspections, and prepare for regulatory authority reviews.
Candidate Profile:
- Strong knowledge of quality systems and regulatory frameworks governing medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent understanding of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills to facilitate effective team collaboration.
This role offers the opportunity to leverage expertise in quality assurance and regulatory affairs to drive business growth and success.
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