QA/RA Director

Job Listing No: 9740000

QA/RA Director

Thornshaw Recruitment – Co Wicklow – QA/RA Director On behalf of my client, I am recruiting for a QA/RA Director. The successful candidate will be responsible for leading the RA/QA team within the organization, over 2 sites in Europe, to assure compliance to international quality and regulatory requirements for IVD. This role reports to the Executive Director. Key Responsibilities: Development and implementation of a strong and effective RA/QA strategy. Product submissions/approvals, license renewals, periodic updates, and product company registrations to regulatory agencies (CE, US, China etc) Fulfil role of Management Representative of the Company Management System, and is the main point of contact with QMS certification/notified bodies, regulator, and Competent Authorities (in support of Vigilance reporting as required) Documented QMS. Lead team during external audit (MDSAP) as well as during authorities or customer inspection. Risk Management, Deviation & CAPA Management, Complaint Management, Post Market… – Permanent – Full-time

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