National AI Awards 2025Discover AI's trailblazers! Join us to celebrate innovation and nominate industry leaders.

Nominate & Attend

Regulatory Affairs Specialist (IVD)

Guided Solutions
Dundee City Council
1 year ago
Create job alert

Our client is a US-headquartered multinational medical device business with a market-leading presence across multiple healthcare disciplines. The business runs in a state of perpetual innovation, continually developing new technologies and enhancing the patient experience. Due to their continued growth, they are now looking for aRegulatory Affairs Specialistto join their Dundee office.

As a Regulatory Affairs Specialist you will be primarily responsible for the administration and development of the Switzerland Person Responsible for Regulatory Compliance (PRRC) and UK Responsible Person (RP) activities within the company's diagnostics division according to appropriate procedures and processes. 

Key responsibilities:

Ensure that appropriate oversight of activities is maintained and any updates required are actioned through appointed Quality Management system(s). Demonstrate commitment to the development, implementation, and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies. Act as an initial and ongoing point of contact for customer sites, external regulators, and other parties for Swiss PRRC and UK RP-related requests. Collation of electronic and paper documents to allow the registration or removal of products according to procedures Review and update internal/external databases’ details for products and manufacturers. Administer, deliver, and forward documents related to requests from manufacturers. Communicate any complaints, as appropriate to manufacturers.

To be considered for the role, you must closely match the following criteria:

Experience in medical devices or IVD regulation or regulatory activities Bachelor’s Degree in a related field is required. Experience of PRRC activities previously is desirable but not essential. Experience user in MS Office suite. Excellent administrative, organisational and business support skills, with the ability to multi-task and to work calmly under pressure. Ability to coordinate meetings, to drive results and build relationships. Demonstrated administrative, written and verbal communication, negotiation and influencing skills. Organised, detail-oriented, have a high level of confidentiality.

Related Jobs

View all jobs

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist

Regulatory Affairs Specialist II

Regulatory Affairs Specialist - VAF315

National AI Awards 2025

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 to Present Biotech Concepts to Non-Scientists: A Public Speaking Guide for Job Seekers

In today’s biotechnology job market, your ability to explain complex science clearly is just as important as your lab skills. Whether you're applying for a research role, pitching to investors, or collaborating with marketing teams, you'll often need to present technical information to people without a scientific background. This blog explores how biotechnology job seekers can develop and deliver compelling presentations that make sense to non-scientists. From structuring your content to designing effective slides and using storytelling to bring data to life, these techniques will help you stand out in interviews and on the job.

Biotech Jobs Employer Hotlist 2025: 50 UK Companies Actively Hiring Right Now 

Bookmark this guide – we refresh it every quarter so you always know who’s really expanding their life‑science teams. The UK biotechnology scene is on a tear in 2025. Venture & follow‑on funding hit £3.5 billion last year, up 94 % on 2023, and Q1 2025 alone brought in another £924 million of equity for scaling therapeutics, diagnostics & deep‑tech platforms  bioindustry.org. Meanwhile, Westminster’s new industrial strategy pledges a record £86 billion for science & tech, with life sciences top of the eight “high‑growth” priority sectors . The consequence? Hiring is white‑hot. From big‑pharma giants to gene‑editing start‑ups, employers need research scientists, QC analysts, bioprocess engineers, bioinformaticians, regulatory specialists & commercial leads – right now. Below you’ll find 50 organisations that have posted UK vacancies or announced head‑count growth during the past eight weeks. They’re grouped into five bite‑size categories so you can jump straight to the type of employer – & mission – that excites you. For every entry you’ll see: Main UK hub Example recent vacancy Why it’s worth your time (tech, culture, impact) Use the internal search on BiotechnologyJobs.co.uk to pull up live roles, or set a free alert so fresh openings land in your inbox.

Return-to-Work Pathways: Relaunch Your Biotechnology Career with Returnships, Flexible & Hybrid Roles

Returning to work after a career break can feel like stepping into a new frontier—especially in a fast-evolving sector such as biotechnology. Whether you’ve paused your professional journey for parenting, caring responsibilities or another life chapter, the UK’s biotech industry now offers a variety of return-to-work pathways designed to help you transition back smoothly. From formal returnships and part-time contracts to hybrid and fully flexible roles, these programmes acknowledge the value of your transferable skills and life experience. In this guide tailored for parents and carers, you’ll discover how to: Grasp the current demand for biotech talent in the UK Translate your organisational, communication and resilience skills into the laboratory and beyond Tackle common re-entry challenges with practical solutions Refresh your scientific and technical knowledge through targeted learning Access returnship and re-entry programmes specifically in biotech Find roles that fit around family commitments—be they flexible, hybrid or full-time Balance work with caring duties Navigate applications, interviews and networking in the biotech world Learn from inspiring returner success stories Get quick answers in our FAQ section Whether you’re keen to step back into a research lab, quality control, regulatory affairs or bioinformatics team, this article will map out the steps and resources you need to reignite your biotechnology career.