Regulatory Affairs and Quality Assurance Assistant - Cambridge)

Newton Colmore Consulting
Cambridge
16 hours ago
Create job alert

Regulatory Affairs and Quality Assurance Assistant - Medical Devices - Cambridge

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 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, I would advise making it clear on your CV as this is highly desirable in this role.

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; 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, 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 in this role, I suggest applying immediately or risk missing out.


#J-18808-Ljbffr

Related Jobs

View all jobs

Med Devices Regulatory Affairs & QA Assistant — Growth

Packaging Technologist

Regulatory Affairs Specialist - Pharmaceuticals

Senior Regulatory Affairs Associate

Regulatory Affairs Manager

European Technical Services Manager

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

Jobs

Neurodiversity in Medical Technology Careers: Turning Different Thinking into a Superpower

Medical technology sits at the intersection of health, engineering & innovation. From imaging & diagnostics to digital health apps, wearables & surgical robotics, medtech is about solving complex real-world problems that directly affect patients’ lives. To do that well, the sector needs people who think differently. If you live with ADHD, autism or dyslexia, you may have been told your brain is “too distracted”, “too literal” or “too disorganised” for a regulated, safety-critical industry. In reality, many traits that made school or previous jobs difficult can be huge strengths in medical technology – from pattern-spotting in clinical data to meticulous attention to detail in device testing. This guide is for neurodivergent job seekers exploring medical technology careers in the UK. We’ll cover: What neurodiversity means in a medtech context How ADHD, autism & dyslexia strengths map to common medtech roles Practical workplace adjustments you can ask for under UK law How to talk about your neurodivergence in applications & interviews By the end, you’ll have a clearer sense of where you might thrive in medical technology – & how to turn “different thinking” into a genuine superpower.

Jobs

Medical Technology Hiring Trends 2026: What to Watch Out For (For Job Seekers & Recruiters)

As we move into 2026, the medical technology (MedTech) jobs market in the UK is changing fast. Hospitals and health systems are under pressure to do more with less. Diagnostics and devices are becoming smarter, more connected and more regulated. AI, robotics and remote monitoring are no longer “future tech” – they’re being built into mainstream care pathways. At the same time, budgets are tight, funding cycles are uneven and some healthtech start-ups are consolidating or being acquired. That means fewer vague “innovation” roles and more focus on medical technology jobs that directly support regulatory approval, patient safety, NHS adoption and commercial growth. Whether you are a MedTech job seeker planning your next move, or a recruiter building teams for medical device, diagnostics or digital health companies, this guide breaks down the key medical technology hiring trends for 2026.

Jobs

Medical Technology Recruitment Trends 2025 (UK): What Job Seekers Need To Know About Today’s Hiring Process

Summary: UK medical technology hiring has shifted from title‑led CV screens to capability‑driven assessments that emphasise regulatory‑aware product delivery (QMS, ISO 13485), software lifecycle & risk (IEC 62304/14971), usability (IEC 62366), clinical & regulatory strategy (MDR/UKCA), device cyber security & privacy, and measurable patient/clinical and commercial impact. This guide explains what’s changed, what to expect in interviews & how to prepare—especially for SaMD engineers, AI/ML in medical devices, product & quality engineers, regulatory/clinical affairs specialists, validation/verification, manufacturing/operations, and digital health roles. Who this is for: Software/firmware engineers in medtech, SaMD/AI engineers, systems & verification engineers, quality & regulatory affairs (QARA), clinical evaluation/PMCF specialists, human factors engineers, medical device cyber security & privacy, test/validation, manufacturing & operations, field/service engineers, and medtech product managers in the UK.

🍪 We use cookies to enhance your browsing experience on our website. By continuing to use this site, you consent to the use of cookies as described in our Cookie Policy. You can review our Cookie Policy for more information.