Head of Quality Assurance and Regulatory Affairs (7 years experience, £65k, Medical Devices, London)

Job Summary

We have an exciting opportunity for a Head of Quality Assurance and Regulatory Affairs role in a Medical Equipment Manufacturing company. The company develops smart wearable technology. It is looking for an experienced individual who can understand and respond to client needs and difficulties while leading a small, focused team in a fast paced startup environment.

Requirements

• A bachelor's degree in a science or engineering discipline is required.
• Extensive expertise in the biotech/medical device industry, with an emphasis on IVD.
• Working knowledge of medical equipment classified as Class I and Class II.
• Excellent ability to communicate.
• 7+ years of combined Quality Assurance, Regulatory, and Clinical Affairs expertise.
• Experience working in a mid sized or start up environment is required.
• Established solid working relationships with regulatory agencies.
• Capable of organising, prioritising, and executing to meet company objectives.
• Knowledge of ISO 13485, MDSAP, IVDR, and GxP regulations.
• Basic understanding of software nomenclature, testing, validation, and user requirements, as well as IQ/OQ/PQ.
• Considerable experience as the key point of contact for regulatory audits/inspections.
• Expert project management abilities are required to develop and implement RA/QA/CA plans.
• Cross functional leadership abilities.