23 Aug HEAD OF QA & RA – RE-USABLE DIAGNOSTIC / ANALYTIC EQUIPMENT N.E.C. – MEDICAL DEVICES – BIRMINGHAM
About our Client:
Our client provides specialist diagnostic products to clinicians and laboratory professionals. Their people are dedicated to improving patient lives, delivering innovative medical solutions that improve the diagnosis and management of blood cancers and immune system disorders.
They are seeking a Head of QA/RA on behalf of an innovative, rapidly expanding medical devices company. This is a rare opportunity to join an inventive organisation who are at the cusp of huge growth and lead a very knowledgeable quality and regulatory team taking their products into new territories globally.
As the Head of QA & RA you will report directly in to the CEO and be responsible for managing a small team of high performing quality and regulatory professionals with a view to grow the team over the next 2-3 of years.
You will manage all ongoing activities to ensure compliance with FDA and MDR regulations, including appropriate international standard such as ISO13485. You will also lead pre and post market function within the regulatory team such as US 510K approval and Post Mark Surveillance.
Essential Experience and Skills:
- To be considered for this role it is essential that you have strong leadership experience and can demonstrate your ability to lead and grow teams.
- Substantial medical devices experience is a prerequisite along with experience of gaining regulatory approvals for class II or above medical devices within the EU and US.
- Familiarity with the requirements for QSR FDA 21 CFR pt. 820, ISO13485 and other applicable standards is essential.
- Knowledge of Programmable Electronic Medical Systems (PEMS).
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