Regulatory Affairs Consultant - Medical Devices IVD/CDx (home or office based)

Parexel
Uxbridge
3 months ago
Applications closed

Related Jobs

View all jobs

Regulatory Affairs Executive

CMC Regulatory Consultant - Permanent

Electronics Engineer Consultant - Security Clearance

Medical Devices Consultant - Senior Mechanical Engineer

Packaging & Regulatory Coordinator

Packaging & Regulatory Coordinator

Regulatory Affairs Consultant - Medical Devices IVD/CDx (home or office based)

Parexel Uxbridge, England, United Kingdom


About The Role We are seeking an experienced Regulatory Affairs professional specializing in in‑vitro diagnostics (IVD) and Companion Diagnostics (CDx) to join our Global Regulatory Affairs team. In this strategic role, you will provide expert guidance on regulatory pathways for IVD and CDx development, clinical trials, and marketing authorizations while collaborating with cross‑functional teams and external partners.


Key Responsibilities



  • Develop and align global regulatory strategies for companion diagnostics across clinical trials, marketing authorizations, and lifecycle management.
  • Collaborate with IVD and CDx partners and Clinical Measurement Sciences (CMS) teams to integrate regulatory considerations into IVD and CDx development plans.
  • Ensure alignment between global and regional IVD and CDx regulatory strategies, involving local GRA teams as needed.
  • Draft and review IVD and CDx‑related content for drug/device regulatory submissions.
  • Lead or support regulatory agency interactions, including document preparation and meeting coordination.
  • Manage IVD and CDx‑specific submissions (e.g., Performance Study Applications in the EU) and responses to agency queries.
  • Provide comprehensive regulatory risk assessments and communicate risks to internal stakeholders.
  • Serve as a subject matter expert on Global Project Team Regulatory Sub‑teams.
  • Support IVD/CDx partner selection processes, due diligence activities, and contracting.
  • Offer specialized regulatory consultation on IVD and CDx.
  • Participate in cross‑functional and GRA initiatives to advance organizational objectives.

Skills And Experience Required For The Role



  • University degree in a scientific discipline, technical or life science degree required, biopharmaceutical, bioscience related science discipline.
  • Minimum 5+ years of experience in Medical Device/IVD regulatory affairs.
  • Extensive knowledge of international regulations for Medical Devices/IVD, with particular expertise in US and EU regulatory frameworks.
  • Demonstrated experience with in‑vitro diagnostics and companion diagnostics regulatory pathways and regulatory submissions.
  • Strong understanding of the drug‑diagnostic co‑development model.
  • Experience working with regulatory agencies on IVD and CDx matters.
  • Fluent in English, written and spoken.
  • Experience also in medical devices and/or combination products would be a plus.
  • Proficiency with regulatory systems including Veeva and TrackWise would be a plus.

Seniority level Mid‑Senior level


Employment type Full‑time


Job function Business Development and Consulting


Industries Pharmaceutical Manufacturing, Biotechnology Research, and Hospitals and Health Care


#J-18808-Ljbffr

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.