Quality Assurance & Regulatory Affairs Manager

Buckingham
9 months ago
Applications closed

Related Jobs

View all jobs

QARA Manager

Quality and Regulatory Affairs Manager

Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics

Senior Manager, Quality Assurance & Regulatory Affairs- UKI & Nordics

Clinical Trials Regulatory & QA Governance Lead

Director, Regulatory Affairs - NPI

Quality Assurance & Regulatory Affairs Manager
Location: Buckinghamshire
Sector: Life Sciences
Salary: circa £65,000
Our client is an established life sciences business based in Buckinghamshire. They distribute and manufacture high-quality and innovative products, including in-vitro diagnostics, laboratory reagents, and biological materials, across the European life sciences market.
An opportunity has become available for an experienced Quality Assurance and Regulatory Affairs Manager to join the company on a permanent basis. Ideally, this will be an on-site position; however, some hybrid flexibility may be available depending on circumstances.
The Role:
This is a key role within the Quality and Regulatory team, responsible for managing a small team across Production and Quality. Reporting to the Managing Director, the successful candidate will serve as the primary contact and person responsible for Quality and Regulatory Compliance across the business. Key responsibilities include:

  • Implementing quality and regulatory directives to ensure compliance
  • Maintaining the company's Quality Management Systems (QMS) in line with ISO 9001, ISO 13485, and ISO 17025
  • Ensuring regulatory compliance for in vitro diagnostics – IVDD/IVDR and CE marking
  • Leading audits in accordance with ISO 13485, ISO 9001, and ISO 17025
  • Handling non-conformities and deviations
  • Managing a small Quality and Production team to ensure project delivery aligns with company expectations
    Suitable Applicants:
    Given the responsibilities of this role, we are seeking a candidate with prior experience within the Life Science sector in a senior Quality and Regulatory position, demonstrating competencies in the following areas:
  • Proven experience in the implementation and maintenance of Quality Management Systems
  • In-depth knowledge of ISO 13485, ISO 9001, and ISO 17025
  • Experience leading ISO-accredited audits
  • Sound knowledge of IVDD and IVDR regulations and CE marking
  • Strong communication skills and strategic thinking abilities
  • Team management experience with a hands-on leadership approach
    In return, our client offers the opportunity to join the company on a permanent basis in a pivotal role. The position offers a salary of circa £65,000 (dependent on experience), along with benefits

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.

Careers

How Many Medical Technology Tools Do You Need to Know to Get a Medical Technology Job?

If you’re pursuing a career in medical technology, it can feel like the toolkit is endlessly long: imaging systems, data analysis software, regulatory platforms, testing frameworks, prototyping tools, CAD, quality management systems, signal processing libraries and more. Scroll job boards or LinkedIn, and it’s easy to think you need to know every tool under the sun just to secure an interview. Here’s the honest truth most hiring managers won’t explicitly tell you: 👉 They don’t hire you because you know every tool — they hire you because you understand the underlying principles and can apply the right tool in the right context to solve real problems. Tools matter — absolutely — but they are secondary to problem-solving ability, clinical awareness, engineering rigour and the ability to deliver safe, reliable solutions. So how many medical technology tools do you actually need to know to get a job? For most job seekers, the answer is far fewer than you think. This article explains what employers really want, which tools are core, which are role-specific, and how to focus your learning so you look confident, competent and end-game ready.

Jobs

What Hiring Managers Look for First in Medical Technology Job Applications (UK Guide)

Medical technology (MedTech) is one of the most dynamic and high-impact sectors in the UK — spanning medical devices, diagnostics, digital health, AI-assisted systems, wearables, imaging, robotics and clinical software. At the same time, hiring managers are exceptionally selective because MedTech roles demand technical excellence, regulated safety awareness, clinical context and cross-disciplinary collaboration. Whether you’re applying for roles in R&D, engineering, quality & regulatory, clinical validation, product management or software development for medical systems, hiring managers don’t read every word of your CV. They scan it quickly — often deciding within the first 10–20 seconds whether to continue reading. This guide breaks down exactly what hiring managers look for first in medical technology applications — and how you can make your CV, portfolio and cover letter stand out in the UK market.

Education

The Skills Gap in Medical Technology Jobs: What Universities Aren’t Teaching

Medical technology — also known as medtech — is transforming healthcare. Innovations in diagnostics, imaging, wearable sensors, robotics, telehealth, digital therapeutics and advanced prosthetics are improving outcomes and saving lives. As the UK’s National Health Service (NHS) modernises and a thriving life sciences sector expands, demand for medtech professionals is growing rapidly. Yet employers across the UK consistently report a frustrating problem: many graduates are not ready for real medtech jobs. Despite strong academic credentials, candidates often lack the practical, interdisciplinary skills needed to contribute effectively from day one. This is not a question of effort or intelligence. It is a widening skills gap between university education and the applied demands of medical technology roles. This article explores that gap in depth — what universities are teaching well, where programmes fall short, why the gap persists, what employers actually want, and how jobseekers can bridge the divide to build thriving careers in medical technology.

🍪 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.