Regulatory Affairs Specialist

Regulatory Affairs Specialist – Hybrid

Are you ready to play a key role in ensuring innovative medical devices reach global markets safely and compliantly? We’re looking for a proactive and detail-driven Regulatory Affairs Specialist to join a growing healthcare manufacturer with an international footprint and a mission to enhance lives through high-quality medical products.

In this role, you’ll take ownership of creating and reviewing medical device technical files, ensuring full compliance with EU MDR and other international regulations. You’ll collaborate closely with regulatory, quality and design teams, while also supporting stakeholders with expert regulatory guidance.

What you’ll be doing:

• Creating and reviewing technical files for medical devices
• Supporting the development of test reports, risk management files, clinical evaluations, PMS documentation and more
• Ensuring products meet all relevant UK, EU and international regulatory requirements
• Providing clear, confident regulatory advice across the business
• Contributing to continuous improvement and maintaining exceptional documentation standards

What you’ll bring:

• Experience working with Class I or higher medical devices
• Hands-on technical file creation and strong EU MDR knowledge
• Excellent attention to detail, communication and problem-solving skills
• The ability to work independently while collaborating effectively across teams

This is a fantastic opportunity for someone who thrives in a fast-paced environment, enjoys autonomy, and wants to make a meaningful impact in a company committed to innovation, integrity and continuous improvement.

If you’re passionate about advancing healthcare through regulatory excellence, we’d love to hear from you.

Unless otherwise stated, if applying for a job within the UK or European Union, you must ensure that you are already authorised to work there.
Carrot Recruitment acts as an Employment Business and an Employment Agency on behalf of our client in recruitment for this role.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, colour, sex, age, national origin, religion, sexual orientation, gender identity and/or expression.

If there are any arrangements or adjustments we can make to assist you at interview then please let us know and we’ll be more than happy to assist.