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- Tasks: Lead quality assurance and regulatory affairs in the medical device sector.
- Company: Innovative tech business focused on medical devices.
- Benefits: Competitive salary, career growth, and a chance to impact healthcare.
- Why this job: Join a dynamic team and ensure compliance for life-changing products.
- Qualifications: Experience in Quality Assurance, medical devices, and ISO13485.
- Other info: Collaborate with R&D and operations in a fast-paced environment.
The predicted salary is between 50000 - 65000 £ per year.
My client, an innovative technology business within the medical device sector, are seeking a Quality Assurance & Regulatory Affairs Manager to join their team. Working closely with senior leadership, R&D and operations, you will play a pivotal role in bringing products to market efficiently and compliantly.
Key responsibilities will include but are not limited to:
- Leading and developing the company’s Quality Management System
- Managing change control activities across products, processes and documentation
- Overseeing product and process validation activities in collaboration with technical teams
- Ensuring effective quality control processes across materials and finished products
- Driving compliance across risk management, CAPA and audit activities
- Supporting regulatory submissions and maintaining compliance across EU and US markets
- Acting as a key contact for regulatory bodies and external stakeholders
- Managing post-market activities, including complaints and ongoing product compliance
The successful candidate will have:
- Strong experience within Quality Assurance and Regulatory environments
- Background within medical devices
- Solid understanding of ISO13485 and 510K FDA submissions
- Experience working cross-functionally with technical and operational teams
- A detail-focused, methodical approach with strong organisational skills
If this opportunity sounds like the right next step for you, please contact Liam for more information or click apply now. We aim to respond to every applicant. However, if you have not heard from us within 10 days, please assume that on this occasion your application has been unsuccessful or the role has now been filled. You are welcome to contact our office or email us to discuss other opportunities.
Quality Assurance & Regulatory Affairs Manager in Cambridge employer: Eclectic Recruitment Ltd
Contact Detail:
Eclectic Recruitment Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance & Regulatory Affairs Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to people in the medical device sector, especially those in Quality Assurance and Regulatory Affairs. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of ISO13485 and 510K FDA submissions. We want you to be able to showcase your expertise confidently, so practice answering questions related to compliance and quality management systems.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values and career goals. Use our website to find roles that excite you, and tailor your approach to each one. Show them why you’re the perfect fit!
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in keeping you top of mind. Plus, it shows your enthusiasm for the role and helps build a connection with the hiring team.
We think you need these skills to ace Quality Assurance & Regulatory Affairs Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Quality Assurance and Regulatory Affairs, especially within the medical device sector. We want to see how your skills align with the job description, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this role. Mention specific experiences that relate to managing quality systems and regulatory submissions, and show us your passion for the industry.
Be Detail-Oriented: Since this role requires a methodical approach, make sure your application is free from typos and errors. We appreciate attention to detail, so double-check everything before hitting send. It’s all about making a great first impression!
Apply Through Our Website: We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you’re keen on joining our team!
How to prepare for a job interview at Eclectic Recruitment Ltd
✨Know Your Standards
Make sure you’re well-versed in ISO13485 and 510K FDA submissions. Brush up on the latest regulations and guidelines, as this will show your potential employer that you’re not just familiar with the standards but also passionate about compliance.
✨Showcase Your Cross-Functional Skills
Prepare examples of how you've successfully collaborated with R&D and operations teams in the past. Highlighting your ability to work across different departments will demonstrate your versatility and value to the company.
✨Be Detail-Oriented
Since the role requires a methodical approach, come prepared with specific instances where your attention to detail made a difference. Whether it was in managing change control activities or overseeing product validation, concrete examples will make your case stronger.
✨Engage with Regulatory Knowledge
Familiarise yourself with the regulatory bodies relevant to the medical device sector. Being able to discuss your experience in managing post-market activities and compliance will set you apart as a candidate who understands the bigger picture.