At a Glance
- Tasks: Support the Quality Assurance and Regulatory Affairs Manager in developing life-changing medical devices.
- Company: Dynamic medical devices company based in Cambridge with a focus on innovation.
- Benefits: Competitive salary, excellent benefits package, career progression, and share options.
- Other info: Fast-growing company with opportunities for personal and professional development.
- Why this job: Join a team that directly impacts healthcare and improves lives globally.
- Qualifications: 1st or 2:1 degree in engineering or sciences; experience in regulatory affairs or quality assurance.
The predicted salary is between 51750 - 63250 £ per year.
Due to the growth of a medical devices company based in Cambridge, there is 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 provide quality assurance and regulatory affairs advise 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; this is a team where 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 would be ideal if you have both quality assurance and regulatory affairs knowledge.
However, people have moved into this role from either regulatory affairs or quality assurance background, but with a general knowledge in the other side.
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, I would advise making 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, excellent salary, 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.
I expect a lot of interest in this role, and the company are looking to recruit quickly.
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Regulatory Affairs and Quality Assurance Assistant – Medical Devices in Cambridge employer: Newton Colmore Consulting
Join a dynamic mechanical engineering services company that prioritises employee growth and development, offering clear progression pathways and a supportive work culture. With a focus on building long-term relationships and delivering exceptional service, you'll thrive in an environment that values your expertise and encourages innovation. Located centrally in Hampshire, this role provides the unique advantage of engaging with diverse industrial sectors across the South Coast, ensuring your contributions have a meaningful impact on the business's success.
