Quality Assurance & Regulatory Affairs Director

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. Key Responsibilities: 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 companys Quality and Regulatory strategy. Prepare the regulatory strategies to support registration and approval of the Companys products. Act as point of liaison between the companys customers and regulatory authorities including FDA and MHRA. Essential Skills: 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. Advertised through Zoek c05584a72d50466b84c53ac3aa983d967