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- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in ensuring compliance for medical devices.
- Company: Join a leading medical devices company in Cambridge, known for innovation and quality.
- Benefits: Enjoy career progression, competitive salary, benefits, and share options.
- Why this job: Be part of an innovative team making a real impact in healthcare.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs preferred.
- Other info: Work permit may be required for non-passport holders of the country.
The predicted salary is between 28800 - 48000 £ per year.
Regulatory Affairs and Quality Assurance Assistant – Cambridge, Cambridge
Client: Newton Colmore Consulting Ltd
Location: Cambridge, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference:
29261556f9ee
Job Views:
6
Posted:
27.06.2025
Job Description:
We are seeking a Regulatory Affairs and Quality Assurance Assistant for a medical devices company based in Cambridge. The successful candidate will support the company\’s Quality Assurance and Regulatory Affairs Manager, providing advice on product creation and improvement, and ensuring compliance with standards such as FDA 510k, ISO 13485, and FDA 21 CFR Part 820.
Knowledge of design processes is advantageous but not essential. The role involves collaboration with R&D teams, especially in relation to regulatory submissions, although writing submissions is not the primary responsibility.
Applicants should have experience with medical devices regulations, particularly ISO 13485 and FDA 510k. QMS experience is highly desirable and should be highlighted on your CV.
Candidates should hold a 1st or 2:1 degree in engineering or sciences and have some experience in regulatory affairs or quality assurance. Experience within a medical devices R&D or design team is preferred.
The company offers career progression, a competitive salary, benefits, and share options. If you are passionate about medical devices and regulatory affairs, apply now to join this innovative team.
For more information, contact Andrew Welsh, Director of Medical Devices Recruitment at Newton Colmore Consulting, at +44 121 268 2240, or apply directly through our platform.
Note: If you are not a passport holder of the country where the vacancy is located, a work permit may be required. Please check our blog for more information.
All applications should be submitted via the \’Apply now\’ button. Do not share bank or payment details during the application process.
Created on 27/06/2025 by TN, United Kingdom
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Regulatory Affairs and Quality Assurance Assistant - Cambridge employer: Newton Colmore Consulting Ltd
Contact Detail:
Newton Colmore Consulting Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs and Quality Assurance Assistant - Cambridge
✨Tip Number 1
Familiarise yourself with the specific regulations mentioned in the job description, such as FDA 510k and ISO 13485. Being able to discuss these standards confidently during an interview will show your genuine interest and understanding of the role.
✨Tip Number 2
Network with professionals in the medical devices field, especially those involved in regulatory affairs and quality assurance. Attend industry events or join relevant online forums to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Research the company’s recent projects and innovations in medical devices. This knowledge will not only help you tailor your conversation during interviews but also demonstrate your enthusiasm for their work and how you can contribute.
✨Tip Number 4
Prepare to discuss any relevant experience you have with Quality Management Systems (QMS). Highlighting your practical knowledge in this area can set you apart from other candidates and show that you are ready to hit the ground running.
We think you need these skills to ace Regulatory Affairs and Quality Assurance Assistant - Cambridge
Some tips for your application 🫡
Understand the Role: Read the job description carefully to understand the key responsibilities and requirements for the Regulatory Affairs and Quality Assurance Assistant position. Make sure you highlight relevant experience in your application.
Tailor Your CV: Customise your CV to emphasise your experience with medical devices regulations, particularly ISO 13485 and FDA 510k. Include any relevant QMS experience and ensure your educational qualifications are clearly stated.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical devices and regulatory affairs. Mention specific experiences that align with the role and express your enthusiasm for contributing to the company's success.
Follow Application Instructions: Ensure you apply through the 'Apply now' button on our platform. Double-check that all required documents are included and that your application is submitted before the deadline.
How to prepare for a job interview at Newton Colmore Consulting Ltd
✨Know Your Regulations
Familiarise yourself with key regulations such as FDA 510k and ISO 13485. Being able to discuss these standards confidently will show your understanding of the industry and impress the interviewers.
✨Highlight Relevant Experience
Make sure to emphasise any experience you have in regulatory affairs or quality assurance, especially within medical devices. Use specific examples from your past roles to demonstrate your skills and knowledge.
✨Showcase Team Collaboration Skills
Since the role involves working closely with R&D teams, be prepared to discuss how you've successfully collaborated with others in previous positions. Highlight any projects where teamwork was essential to achieving compliance or improving processes.
✨Prepare Questions
Have a few thoughtful questions ready to ask at the end of the interview. This shows your genuine interest in the role and the company, and it gives you a chance to learn more about their expectations and culture.
