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- Tasks: Lead compliance for innovative health tech products and ensure regulatory readiness.
- Company: Rapidly growing health tech start-up in Stevenage focused on wearable technology.
- Benefits: Competitive salary, holiday package, pension scheme, and a supportive work environment.
- Why this job: Make a real difference in healthcare while developing your compliance expertise.
- Qualifications: Experience with ISO 13485 and UKCA/CE regulations is essential.
- Other info: Join a dynamic team with opportunities for professional growth.
The predicted salary is between 50000 - 60000 £ per year.
Location: Stevenage
Salary: £50,000-£60,000 (dependent on experience)
Compliance Manager required for our client based in Stevenage, they are a rapidly growing UK-based health tech start-up that is 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. You will ensure our documentation, processes, and evidence are audit-ready and proportionate to the company's stage.
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; with ISO 9001 where useful).
- Own and maintain the product Technical File / Technical Documentation, ensuring it is complete, current, and defensible.
- Ensure traceability from requirements → risk controls → verification/validation → release.
- 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.
Salary - £50,000-£60,000 (dependent on experience)
Monday to Friday (09:00 to 17:00)
On-site position
Holiday package
Pension scheme
Compliance Manager in Stevenage 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 Compliance Manager in Stevenage
✨Tip Number 1
Get to know the company inside out! Research their products, values, and recent news. This will help you tailor your conversations and show that you're genuinely interested in being part of their team.
✨Tip Number 2
Network like a pro! Connect with current employees on LinkedIn or attend industry events. A friendly chat can sometimes lead to insider tips or even a referral, which can give you a leg up in the hiring process.
✨Tip Number 3
Prepare for the interview by practising common compliance-related questions. Think about how your experience aligns with their needs, especially around ISO 13485 and regulatory pathways. Confidence is key!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, we love seeing candidates who take the initiative to engage directly with us.
We think you need these skills to ace Compliance Manager in Stevenage
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. 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!
Showcase Relevant Experience: When detailing your experience, focus on specific projects or roles where you've led compliance initiatives. We love seeing concrete examples of how you've managed QMS or coordinated with external test labs.
Apply Through Our Website: Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. We can't wait to hear from you!
How to prepare for a job interview at Bennett and Game Recruitment LTD
✨Know Your Compliance Stuff
Make sure you brush up on ISO 13485 and the UKCA/CE regulatory pathways. Be ready to discuss your experience with QMS implementation and how you've handled audits in the past. This shows you're not just familiar with the standards, but that you can apply them effectively.
✨Showcase Your Coordination Skills
Since this role involves working with external test labs and regulatory consultants, prepare examples of how you've successfully coordinated with different stakeholders. Highlight any challenges you faced and how you overcame them to keep projects on track.
✨Be Audit-Ready
Talk about your approach to maintaining documentation and processes that are audit-ready. Share specific instances where you ensured compliance and how you prepared for external audits. This will demonstrate your proactive mindset and attention to detail.
✨Align with Company Goals
Research the company’s mission and values, especially their focus on supporting people with neurological conditions. Be prepared to discuss how your compliance strategies can align with their goals and enhance their product offerings. This shows you're not just a fit for the role, but also for the company culture.
