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- Tasks: Lead compliance for innovative health tech, ensuring quality and regulatory standards are met.
- Company: Rapidly growing UK health tech start-up focused on wearable technology.
- Benefits: Competitive salary, holiday package, pension scheme, and a supportive work environment.
- Other info: Join a dynamic team with opportunities for professional growth and development.
- Why this job: Make a real difference in healthcare by supporting people with neurological conditions.
- Qualifications: Experience with ISO 13485 and UKCA/CE regulatory pathways required.
The predicted salary is between 60000 - 80000 £ per year.
Compliance Manager required for our client based in Stevenage, they are a rapidly growing UK-based health tech start-up that's building wearable technology with the power to support people living with neurological conditions. They are looking for a Compliance Manager to own our compliance roadmap end-to-end: building and maintaining a compliant QMS (ISO 13485-aligned), managing certification/technical documentation for UKCA/CE (UK/EU), coordinating FCC for the US market, as well as other markets and leading external audits and test houses.
This role sits at the interface of engineering, operations, suppliers, and (where needed) regulatory consultants/notified bodies.
Compliance Manager Overview- Own our regulatory plan for UKCA (UK), CE marking (EU), and FCC (US), aligned to product claims, intended use, risk classification, and target markets.
- Maintain a compliance matrix covering applicable standards and regulations (e.g., EMC, electrical safety, biocompatibility if relevant, labelling/IFU, UDI where applicable).
- Coordinate with external test labs, regulatory consultants, and (if applicable) Notified Bodies / UK Approved Bodies.
- Ensure product marketing claims remain consistent with regulatory positioning and evidence.
- Design, implement, and maintain a Quality Management System suitable for a medical device manufacturer (typically ISO 13485; risk controls).
- Experience leading ISO 13485 (or equivalent medical-device QMS) implementation and/or maintenance, including external audits.
- Strong working knowledge of UKCA/CE regulatory pathways for medical devices and associated technical documentation expectations.
- Experience coordinating EMC/radio/safety testing and managing third-party test houses.
- Practical experience with CAPA, document control, change control, supplier quality, and complaint handling.
- Monday to Friday (09:00 to 17:00)
- Holiday package
- Pension scheme
Director, Regulatory & Quality Compliance employer: Bennett and Game Recruitment LTD
Contact Detail:
Bennett and Game Recruitment LTD Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director, Regulatory & Quality Compliance
✨Tip Number 1
Network like a pro! Reach out to people in the health tech industry, especially those who work with compliance. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Show off your expertise! Prepare a portfolio or presentation that highlights your experience with ISO 13485 and regulatory pathways. This will help you stand out during interviews and show that you mean business.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers, especially around compliance challenges you've faced. The more comfortable you are, the better you'll perform when it counts.
✨Tip Number 4
Don't forget to apply through our website! We’ve got loads of opportunities waiting for you, and applying directly can sometimes give you an edge over other candidates. Let's get you that Compliance Manager role!
We think you need these skills to ace Director, Regulatory & Quality Compliance
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Compliance Manager role. Highlight your experience with ISO 13485 and any relevant regulatory pathways like UKCA and CE marking. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about compliance in health tech and how you can contribute to our mission. Keep it concise but impactful, and don’t forget to mention your experience with external audits.
Showcase Relevant Experience: When detailing your work history, focus on experiences that relate directly to the role. Talk about your hands-on experience with QMS, CAPA, and managing third-party test houses. We love seeing practical examples of your achievements!
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It helps us keep everything organised and ensures your application gets the attention it deserves. Plus, it’s super easy!
How to prepare for a job interview at Bennett and Game Recruitment LTD
✨Know Your Compliance Inside Out
Make sure you’re well-versed in ISO 13485 and the UKCA/CE regulatory pathways. Brush up on the specifics of compliance documentation and be ready to discuss how you've implemented or maintained a QMS in your previous roles.
✨Showcase Your Coordination Skills
This role involves liaising with various stakeholders, so prepare examples of how you've successfully coordinated with external test labs, regulatory consultants, and notified bodies. Highlight your experience in managing audits and testing processes.
✨Align Product Claims with Regulations
Be prepared to discuss how you ensure that product marketing claims are consistent with regulatory requirements. Think of specific instances where you’ve had to balance compliance with marketing needs and how you navigated that.
✨Demonstrate Problem-Solving Abilities
Compliance can often involve unexpected challenges. Prepare to share examples of how you've handled CAPA, document control, or supplier quality issues. Show them you can think on your feet and find solutions under pressure.