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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 essential.
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 Affairs & Quality 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 Affairs & Quality in Watford
✨Tip Number 1
Network like a pro! Reach out to people in the health tech industry, especially those involved in regulatory affairs. Attend events or webinars where you can connect with potential employers and learn more about the field.
✨Tip Number 2
Showcase your expertise! Prepare a portfolio that highlights your experience with ISO 13485 and regulatory pathways. This will help you stand out during interviews and demonstrate your knowledge in compliance management.
✨Tip Number 3
Practice makes perfect! Conduct mock interviews with friends or mentors to refine your answers, especially around compliance topics. This will boost your confidence and help you articulate your experience effectively.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of opportunities in the health tech sector, and applying directly can give you an edge. Plus, it’s super easy to keep track of your applications!
We think you need these skills to ace Director, Regulatory Affairs & Quality in Watford
Some tips for your application 🫡
Tailor Your CV: Make sure your CV speaks directly to the role of Compliance Manager. 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 the perfect fit for our health tech start-up. Share your passion for compliance and how you can contribute to our mission of supporting people with neurological conditions.
Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles where you've led compliance initiatives or managed quality systems. We love seeing concrete examples that demonstrate your expertise in regulatory affairs and quality management.
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 the role. Plus, it shows you’re keen on joining our team at StudySmarter!
How to prepare for a job interview at Bennett and Game Recruitment LTD
✨Know Your Regulations Inside Out
Make sure you’re well-versed in UKCA, CE marking, and FCC regulations. Brush up on the specifics of ISO 13485 and be ready to discuss how you've implemented or maintained a QMS in the past.
✨Showcase Your Experience with Audits
Prepare examples of your experience leading external audits and managing compliance documentation. Be ready to explain how you’ve coordinated with test labs and regulatory consultants in previous roles.
✨Demonstrate Cross-Functional Collaboration
This role interfaces with various teams, so highlight your experience working with engineering, operations, and suppliers. Share specific instances where your collaboration led to successful compliance outcomes.
✨Align Marketing Claims with Regulatory Standards
Be prepared to discuss how you ensure that product marketing claims are consistent with regulatory positioning. Think of examples where you’ve had to balance compliance with marketing needs.