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3 days ago
We are seeking a seasoned professional to assume the role of Medical Device Quality Assurance Leader. This is an exciting opportunity for an executive with expertise in quality assurance and regulatory affairs.
The successful candidate will play a critical role in ensuring compliance with international quality standards and regulatory requirements.
- Main Responsibilities:
- Develop and implement effective quality management systems to meet ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Collaborate with regulatory bodies, including local FDA and CDSCO, to obtain necessary permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for medical devices.
- Coordinate regulatory submissions and ensure timely approvals.
- Manage Corrective and Preventive Actions (CAPA) to maintain compliance and drive continuous improvement.
- Support audits, inspections, and prepare for regulatory authority reviews.
Candidate Profile:
- Proven 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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