As Quality & Regulatory Affairs Manager for this established Medical Device company you'll lead a talented team in a high profile role.
 

• A vital, highly visible position as Quality & Regulatory Affairs Manager where you'll engage all areas of the business to maintain and drive quality improvement, including providing regulatory advice to the Board of Directors to ensure sound decision making.
• Lead, manage and coach a team of 3 while ensuring compliance to general, medical device, environmental, distribution and labour standards and regulations. Manage communication and approvals with Competent Authorities (e.g. MHRA) and Notified Bodies (e.g. LRQA). Work closely with the New Product Development Team to bring new products to market, either under our own CE mark or through distribution or similar agreements.
• Based close to High Wycombe, the office is commutable from Maidenhead, Slough, Bracknell, Hayes, Uxbridge, Amersham, Watford, Hemel Hempstead, Aylesbury, etc.

COMPANY

• A well-established and award-winning medical device company ensuring significant improvements to patients' quality of life by providing quality products and outstanding customer care.

REQUIREMENTS

• Proven experience in a similar Quality & Regulatory Affairs role working with medical devices / pharmaceuticals with expert knowledge of the Medical Device Directive (MDD), Medical Devices Regulation (MDR), ISO 13485, ISO 14971 and ISO 9001. Qualified 'Person Responsible' for Regulatory Compliance (MDR). Experience in developing quality and regulatory affairs strategy, and interpreting, implementing and communicating regulatory changes. Internal and external auditing experience in addition to managing and developing team members.
• A degree in a Life Science, Pharmaceutical or Engineering discipline, and clear, confident communications skills.

PACKAGE

• Salary of £60-65,000 plus great benefits.

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