Hobson Prior is seeking a Regulatory Affairs/Quality Assurance Specialist to join a diversified advanced medical technology business based in Warwick. The role reports into the Group Manager RA – UKI and Nordics and will be responsible for representing the RAQA function for all Field Safety Corrective Actions (FSCA).
Regulatory Affairs/Quality Assurance Specialist – Warwick
- Manage competent authority reporting activities related to FSN, FSCAs and follow ups
- Report evidence of FSCA closure for each affected country within EUCAN regions
- Ensure all responses related to FSCAs are dealt with in a timely manner, managing competent authority expectations
- Develop and assist in product registrations and re-registrations for Europe and Canada and to existing approved countries for the client’s products
- Develop, review and implement regional policies and procedures based on corporate and regional requirements
- Ensure total compliance and the protection of S&N interests in regulatory aspects of commercial business relationships
- Propose and implement solutions for commercial activities in the EU for RAQA compliance
- Prior experience in regulatory affairs or quality assurance
- Proven knowledge of medical devices standards, for example ISO13485
- A degree level qualification would be advantageous
- Experience working on global products in the past is highly desirable
- Fluency in the English language is essential
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading specialist life science recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.