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- Tasks: Lead compliance efforts for innovative health tech products and ensure regulatory readiness.
- Company: Rapidly growing health tech start-up focused on wearable technology.
- Benefits: Competitive salary, holiday package, pension scheme, and a supportive work environment.
- Why this job: Join a mission-driven team making a real difference in people's lives with cutting-edge technology.
- Qualifications: Experience with ISO 13485 and UKCA/CE regulations is essential.
- Other info: Dynamic role with opportunities for professional growth in a fast-paced industry.
The predicted salary is between 50000 - 60000 £ per year.
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
Contact Detail:
Bennett and Game Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Compliance Manager in Stevenage
✨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 or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO 13485 and UKCA/CE regulations. We want you to be able to discuss how your experience aligns with the role and show off your expertise!
✨Tip Number 3
Don’t just apply anywhere; focus on companies that excite you! Use our website to find roles that match your passion for compliance in health tech. Tailor your approach to each company’s mission.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share a relevant article or insight related to compliance to show your enthusiasm and knowledge.
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 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 audits and technical documentation.
Showcase Relevant Experience: When filling out your application, be sure to showcase your experience with managing compliance processes and coordinating with external test labs. We love seeing practical examples of how you've handled similar responsibilities in the past!
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates. Plus, it’s super easy!
How to prepare for a job interview at Bennett and Game
✨Know Your Compliance Standards
Make sure you brush up on ISO 13485 and the UKCA/CE regulatory pathways. Being able to discuss these standards confidently will show that you’re not just familiar with them, but that you can apply them in a practical setting.
✨Showcase Your Experience
Prepare specific examples from your past roles where you successfully implemented or maintained a Quality Management System. Highlight any experiences with external audits or managing technical documentation, as this will resonate well with the interviewers.
✨Understand the Company’s Products
Research the health tech start-up and their wearable technology. Understanding their products and how compliance plays a role in their development will help you tailor your answers and demonstrate your genuine interest in the company.
✨Prepare Questions for Them
Think of insightful questions to ask about their compliance roadmap and how they handle regulatory challenges. This shows that you’re proactive and engaged, plus it gives you a chance to assess if the company is the right fit for you.
