
Senior Medical Device Quality Assurance Specialist
1 day ago
As a seasoned quality assurance and regulatory affairs expert, this pivotal role demands a strong understanding of quality systems and regulatory frameworks for medical devices.
The ideal candidate will possess hands-on experience with regulatory submissions, post-market surveillance, and risk management.
This includes coordinating with local authorities for obtaining required permissions and approvals, overseeing risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices.
The successful candidate will have excellent knowledge of GMP, GDP, and ISO 13485 standards, as well as strong communication, documentation, and coordination skills.
They will manage regulatory submissions, handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement, and support audits, inspections, and ensure readiness for regulatory authority reviews.
Additionally, they will be responsible for ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
The executive will be expected to work closely with cross-functional teams to drive business growth and improve operational efficiency.
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