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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 in Watford 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 in Watford
✨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! When you get the chance to meet potential employers or attend industry events, don’t be shy about discussing your experience with ISO 13485 and regulatory pathways. It’ll help you stand out as a candidate who knows their stuff.
✨Tip Number 3
Prepare for interviews by brushing up on the latest compliance trends and regulations. Being able to discuss current challenges in the medical device sector will show that you're not just qualified, but also genuinely interested in the field.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities that might be perfect for you. Plus, it’s a great way to ensure your application gets seen by the right people.
We think you need these skills to ace Director, Regulatory & Quality Compliance in Watford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the specific skills and experiences that match the Compliance Manager role. Highlight your experience with ISO 13485 and regulatory pathways like UKCA and CE marking, as these are key for us.
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 your background makes you the perfect fit for our team. Keep it concise but impactful!
Showcase Relevant Experience: When detailing your work history, focus on your achievements related to quality management systems and regulatory compliance. We want to see how you've successfully navigated audits and managed technical documentation.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for this exciting opportunity in our growing start-up!
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 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 other parties. Highlight your experience managing audits and working with third-party test houses.
✨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 marketing needs with compliance standards.
✨Demonstrate Problem-Solving Abilities
Compliance often involves navigating 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.