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- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in ensuring compliance with medical device standards.
- 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 is 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 #J-18808-Ljbffr
Regulatory Affairs and Quality Assurance Assistant - Cambridge employer: JobLeads GmbH
Contact Detail:
JobLeads GmbH 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. This knowledge will not only help you during interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical devices field, especially those working in regulatory affairs or quality assurance. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss any relevant experience you have with Quality Management Systems (QMS) during interviews. Highlighting your practical knowledge in this area can set you apart from other candidates.
✨Tip Number 4
Research the company’s recent projects and innovations in medical devices. Being able to speak about their work shows genuine interest and can help you connect with the interviewers on a deeper level.
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. Highlight your relevant experience in regulatory affairs and quality assurance in your application.
Tailor Your CV: Make sure your CV reflects your experience with medical devices regulations, particularly ISO 13485 and FDA 510k. Emphasise any QMS experience you have, as this is highly desirable for the role.
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 job requirements and explain why you are a good fit for the company.
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 free of errors before submission.
How to prepare for a job interview at JobLeads GmbH
✨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 role and its requirements.
✨Highlight Relevant Experience
Make sure to emphasise any experience you have in regulatory affairs or quality assurance, especially within medical devices. This will help demonstrate your suitability for the position.
✨Prepare for Collaboration Questions
Since the role involves working with R&D teams, be ready to discuss how you’ve successfully collaborated in the past. Share specific examples that showcase your teamwork skills.
✨Show Passion for Medical Devices
Express your enthusiasm for the medical devices field during the interview. Companies appreciate candidates who are genuinely interested in their products and mission.
