Graduate Regulatory Affairs – Medical Devices
4 days ago
Royal Leamington Spa
Graduate Regulatory Affairs Associate – Medical Devices Location: Leamington Spa, UK | Office-based (occasional travel) Reports to: Business Director Join a market-leading healthcare company with over 40 years of global experience. Our client manufactures high-quality medical devices in the UK and supply products to over 70 countries. This is a fantastic opportunity to start your career in a specialist field within the life sciences industry and gain hands-on experience in a growing SME, learning the business from the bottom up. The Role: As a Graduate Regulatory Affairs Associate, you will support the compliance of our medical device portfolio with international regulations. Responsibilities include: • Compliance assurance, • Ensuring that medical devices meet all legal requirements before they are sold, • Product development support, • Guiding the development and lifecycle management of new and existing medical devices to ensure they meet regulatory standards, • Market surveillance, • Monitoring the performance and safety of devices already on the market and reporting any issues to the appropriate regulatory body, • Documentation and submissions, • Preparing and submitting required documentation to regulatory agencies for approval, • Risk assessment, • Analysing and managing the risks associated with medical devices to ensure patient safety, • Liaising with authorities such as the MHRA, • Communicating with regulatory bodies, such as MHRA, to provide information and address concerns While primarily office-based, the role involves occasional travel to manufacturing sites and trade shows, so a full UK driving licence is required. Requirements: • Graduate in Biomedical Engineering, Biochemistry, Life Sciences, or a related discipline, • Strong attention to detail, communication, and analytical skills, • Excellent communication skills, • An understanding of regulatory affairs, • Right to work in the UK (sponsorship not provided) What We Offer: • Competitive salary, • Structured training and mentoring in Medical Regulatory Affairs, • Supportive and Friendly Team, • Exposure to global compliance frameworks and career progression opportunities, • Free on-site parking, early finish at 2:30pm Fridays, company pension scheme