Graduate Regulatory Affairs – Medical Devices

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