Head of Quality & Regulatory Affairs
Position: Head of Quality & Regulatory Affairs
Location: Birmingham, United Kingdom
Remuneration: GBP 100,000 - GBP 150,000 per annum
Vado Med Tech are currently seeking a contract Quality Engineer with hands on experience of resolving complaints, including completion of CAPAs, 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 to work within a very knowledgeable quality team in taking their product 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 years. You will manage all ongoing activities to ensure compliance with FDA and MDR regulations, including appropriate international standards such as ISO13485. You will also lead pre and post market functions within the regulatory team such as US 510K approval and Post Mark Surveillance.
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 as well as knowledge of Programmable Electronic Medical Systems (PEMS).