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- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in medical device projects.
- Company: Join a growing medical devices company in Cambridge making a global impact.
- Benefits: Enjoy career progression, competitive salary, benefits package, and share options.
- Why this job: Work on life-changing products and collaborate with innovative R&D teams.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs is a plus.
- Other info: Apply quickly to avoid missing out on this exciting opportunity!
The predicted salary is between 28800 - 48000 £ per year.
Regulatory Affairs and Quality Assurance Assistant – Medical Devices – Cambridge
Due to the growth of a medical devices company based in Cambridge, there is a need for a new Regulatory Affairs and Quality Assurance Assistant to work with and support the company’s Quality Assurance and Regulatory Affairs Manager. The team provides quality assurance and regulatory affairs advice on the creation of new products and the improvement of existing technologies.
It would be highly advantageous if you have knowledge of design processes, but it’s not essential. This team does not just fill out quality assurance and regulatory documents; they will be very involved with the R&D team, providing vital advice on the creation of medical devices, and ensuring the team operates within the FDA 510k, ISO 13485, and FDA 21 CFR Part 820 standards.
It is essential that you have medical devices knowledge, especially ISO 13485 and FDA 510k knowledge. Although writing submissions will not be a major part of your role, you will relay information to the teams responsible for this, so ideally you will have done this in the past or at least assisted.
Ideally, you will have QMS experience. If you do have this knowledge, please make it clear on your CV as this is highly desirable in this role.
The products this company has been developing are industry-changing and will improve the lives of people around the world.
It is expected that you would hold a 1st or 2:1 degree within an engineering or sciences discipline along with some experience within regulatory affairs or quality assurance. Although experience working within a medical devices R&D or design team is more important than education.
This is a growing company; due to this, they offer career progression, an excellent salary, a benefits package, the chance to work on life-improving devices, and share options.
If you have regulatory affairs knowledge in the medical devices sector and are looking for a challenging role, then apply now.
I expect a lot of interest in this role, and the company is looking to recruit quickly. So, if you are interested, I suggest applying immediately or risk missing out.
For more information, please feel free to call Andrew Welsh, Director of Medical Devices recruitment, Science recruitment and Biotech recruitment specialists Newton Colmore Consulting, on +44 121 268 2240 or make an application, and one of our team at Newton Colmore Consulting will contact you.
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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 FDA 510k and ISO 13485 standards. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to the role and the industry.
✨Tip Number 2
Network with professionals in the medical devices sector, especially those involved in regulatory affairs and quality assurance. Attend relevant industry events or join online forums to make connections that could lead to valuable insights and recommendations.
✨Tip Number 3
Showcase any hands-on experience you have with Quality Management Systems (QMS). Even if it's limited, discussing specific instances where you've contributed to quality assurance processes can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss how you can support the R&D team in developing new medical devices. Think of examples where you've collaborated with cross-functional teams, as this will highlight your ability to work effectively in a dynamic environment.
We think you need these skills to ace Regulatory Affairs and Quality Assurance Assistant – Cambridge
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasise any experience you have in regulatory affairs or quality assurance, particularly within the medical devices sector. Mention specific projects or roles where you applied your knowledge of ISO 13485 and FDA 510k standards.
Tailor Your CV: Customise your CV to reflect the skills and experiences that align with the job description. Include any QMS experience and ensure that your educational background is clearly stated, especially if you hold a degree in engineering or sciences.
Craft a Strong Cover Letter: Write a compelling cover letter that explains why you are interested in this role and how your background makes you a suitable candidate. Be sure to mention your passion for working on life-improving devices and your eagerness to contribute to the team.
Proofread Your Application: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. A polished application reflects your attention to detail, which is crucial in regulatory affairs and quality assurance.
How to prepare for a job interview at Newton Colmore Consulting Ltd
✨Showcase Your Medical Devices Knowledge
Make sure to highlight your understanding of medical devices, particularly ISO 13485 and FDA 510k standards. Be prepared to discuss how your knowledge can contribute to the company's goals and ensure compliance.
✨Demonstrate QMS Experience
If you have experience with Quality Management Systems (QMS), be sure to mention it during the interview. Provide specific examples of how you've applied this knowledge in previous roles, as it's highly desirable for this position.
✨Engage with R&D Discussions
Since the role involves working closely with the R&D team, prepare to discuss how you can provide valuable insights during product development. Think of examples where you've collaborated with technical teams in the past.
✨Express Enthusiasm for Career Progression
This company is growing rapidly, so express your interest in career advancement opportunities. Share your long-term goals and how they align with the company's vision, showing that you're committed to contributing to their success.
