Quality and Regulatory Affairs Manager

Nicholas Associates
Walton-on-Thames
3 weeks ago
Create job alert

Position

Position: Quality Assurance & Regulatory Affairs Manager / Director


Location: Middlesex, West London, Surrey


Please note:



  • You MUST be able to work in the office 5 days per week through your probationary period
  • You MUST have medical devices sector experience in the UK
  • You MUST have the right to work in the UK without restriction


Base pay range

This range is provided by Nicholas Associates. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.


Purpose of the Role

To lead UK quality and regulatory strategy, ensuring compliance across the company's product portfolio. This role is pivotal in enabling market access, maintaining high standards, and embedding quality throughout the product lifecycle.


Strategic Leadership


  • Represent role model or servant leader model leadership as a member of senior site management team.
  • Develop and implement the QARA strategy aligned with business goals and regulatory compliance requirements.
  • Collaborate with Engineering, Operations, and Commercial teams to integrate quality and compliance from concept to delivery.
  • Represent the company in regulatory compliance audits and external engagements.


Regulatory Affairs


  • Oversee global product registrations and submissions, including CE marking and international approvals for company products
  • Support in defining regulatory pathways early in product development, including Intended Use and Risk Classification.
  • Ensure compliance with ISO 13485, MDR, FDA 21 CFR Part 820, and other relevant standards.


Quality Assurance


  • Maintain and enhance the Quality Management System (QMS).
  • Lead internal and supplier audits, investigations, and corrective actions.
  • Analyse QA data to drive continuous improvement and risk mitigation.


Project Oversight


  • Lead QARA team in managing regulatory documentation and audit readiness.
  • Support change control and post-market surveillance activities.


Team Development


  • Mentor and develop QARA team members.
  • Ensure training programmes reflect current regulatory and quality practices.


Skills & Experience


  • Proven leadership in QARA within medical devices or regulated industries.
  • Experience with CE marking, Medical Device Requirements, both EU and UK, regulatory submissions, electrical safety requirements, software validation, and international compliance.
  • Excellent communication and stakeholder engagement skills.
  • Familiarity with electronic QMS and project management tools.


Desirable Qualifications


  • Degree in Engineering, Life Sciences, or related field (Master’s preferred).
  • Experience working directly with regulatory bodies.
  • Lead Auditor Certification


Seniority level


  • Mid-Senior level


Employment type


  • Full-time


Job function


  • Quality Assurance and Management
  • Industries: Medical Equipment Manufacturing and Manufacturing


#J-18808-Ljbffr

Related Jobs

View all jobs

Regulatory Affairs Manager

EU Regulatory Affairs Manager – MedTech

Regulatory Affairs Manager

Regulatory Affairs Senior Manager

Senior Manager, Regulatory Affairs

Associate Director, Regulatory Affairs

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.

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.

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.

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.