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