About the Role:
I am representing an innovative Medical Device company based in Cambridgeshire to find a Quality Assurance & Regulatory Affairs Director to lead the business through new product launches and expanding the existing product portfolio into new territories.
A large part of the job is developing and implementing the QARA strategy so it is imperative the Director is a competent influencer and skilled in collaborating with people at all levels.
- Leading a team of 6 QARA personnel with an important part of the job being to develop and coach this team.
- To develop, implement, maintain and promote the company's Quality and Regulatory strategy.
- Prepare the regulatory strategies to support registration and approval of the Company's products.
- Act as point of liaison between the company's customers and regulatory authorities including FDA and MHRA.
- Minimum of 10 years' experience in a similar role in the Medical Device industry
- Experience with Class III Medical Devices
- Proven management experience and ability to train and coach
- Internal and external auditing (Ideally certified Auditor)
Sthree UK is acting as an Employment Agency in relation to this vacancy.