Regulatory Affairs Specialist

Maidenhead
1 week ago
Create job alert

Are you an experienced Regulatory Affairs specialist or Medical Writer? Do you have experience in the writing / authoring of technical files? If so, we would love to speak with you!

We are recruiting for a Regulatory Affairs Specialist to join our clients Infectious Disease business unit, preparing documentation for international product registrations.

We are looking for someone with an RA or Medical Writing background, preferably within an IVD or medical device manufacturing environment.

This role is fully remote within the UK, Inside IR35 and contracted initially until the end of 2025 working 37.5 hours per week.

Responsibilities:

Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).
Provides regulatory support for diagnostic product development and commercial diagnostic products.
Performs regulatory impact assessments.
Coordinate with internal and external stakeholders to gather necessary information.
Develops regulatory strategies for products in development and for modified products to achieve clearance/approval internationally.
Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments.
Compiles and publishes all material required for submissions, license renewals, and annual registrations.
Maintains approvals/licenses/authorizations for existing marketing authorizations.
Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations.
Organizes and maintains hard copy and electronic department files.
Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.Education and experience:

Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
Previous experience in Regulatory Affairs or Medical Writing.
Strong knowledge of IVDR, EU and international regulatory requirements is preferred.
Demonstrated written and verbal communication skills.
Strong time management skills, with the ability to work on multiple projects simultaneously.
Ability to work independently as well as within a team.
Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business

Related Jobs

View all jobs

Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Regulatory Affairs Manager

Regulatory Affairs Associate

Regulatory Officer

QA Specialist

Get the latest insights and jobs direct. Sign up for our newsletter.

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

Industry Insights

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

Rural-Remote Medical Technology Jobs: Thriving Beyond Urban Hubs

A Fresh Outlook for Medical Technology Professionals When people think of medical technology (MedTech) roles—whether that’s in digital health, medical devices, or health-tech innovation—they typically imagine big-city laboratories, bustling R&D centres, and hospital-adjacent offices. Yet, the landscape is shifting. Advances in telehealth, data analytics, and cloud computing are expanding the range of possibilities. As a result, many MedTech professionals now find they can live and work in picturesque rural areas or by the coast, rather than feeling bound to large urban hubs. At MedicalTechnologyJobs.co.uk, we’ve noticed a growing wave of jobseekers seeking out positions that allow for “tech jobs by the sea” or “medical technology remote countryside.” Employers, keen to attract talent from a broader pool, are discovering that the demands of high-level MedTech work can often be met remotely, provided you have the right tools and connectivity. No longer is it compulsory to live in or near London to make a meaningful contribution to life-saving or life-improving technologies. Below, we’ll unpack why rural-remote MedTech jobs are on the rise, what you need to know if you’re considering swapping the city skyline for rolling hills or ocean views, and how to position yourself for success in this brave new world of flexible medical technology careers.

Quantum-Enhanced AI in Medical Technology—Transforming Healthcare for the Future

Medical technology—or medtech—stands at the forefront of redefining how we diagnose, treat, and manage illness. From MRI scanners that peer deep into our bodies to personalised therapy platforms that predict disease risk, medtech solutions already shape modern healthcare. Yet as the global population grows and health needs become more complex, conventional computational methods face staggering challenges in analysing massive biological datasets, simulating intricate disease pathways, and accelerating drug discovery. This is where quantum computing and Artificial Intelligence (AI) converge to spark a new wave of quantum-enhanced AI—unlocking innovation in medical technology like never before. Why does quantum matter for medtech? Traditional supercomputers rely on binary bits (0 or 1). Quantum computers harness qubits, capable of existing in multiple states simultaneously (superposition) and becoming interlinked (entanglement). The result? Potential exponential or quadratic speed-ups for certain algorithms and simulations—particularly those that involve high-dimensional data, complex protein folding, or combinatorial searches for novel drugs. In parallel, AI—especially machine learning—has already revolutionised medical imaging, diagnostics, and patient monitoring. However, standard AI approaches often choke on the vast computational loads inherent to genome analysis, multi-omics data, or advanced robotics. Quantum computing promises to offload or accelerate some of these computationally intense tasks, enabling more powerful models, faster results, and the potential to discover new correlations hidden within enormous datasets. In this article, we will: Examine the current landscape of medical technology, highlighting computational barriers that hamper progress. Demystify quantum computing and its fundamental differences from classical systems. Explore how quantum-enhanced AI can reshape medtech applications—from drug discovery to diagnostics and beyond. Dive into real-world pilot projects and potential breakthroughs on the horizon. Discuss challenges (like hardware maturity, data encoding, ethics, and patient privacy) and how the industry might overcome them. Highlight career paths, roles, and skill sets that could define the next generation of medtech professionals. If you’re involved in medical device development, healthcare data analysis, or simply curious about the future of medicine, read on. Quantum-enhanced AI has the potential to supercharge healthcare innovation, improving patient outcomes while driving exciting new career opportunities.

Medical Technology Jobs at Newly Funded UK Start-ups: Q3 2025 Investment Tracker

Medical technology is transforming healthcare worldwide. From AI-driven diagnostics to state-of-the-art wearable devices and advanced surgical robotics, medtech innovations are enhancing patient outcomes and reshaping the way care is delivered. In the UK, a dynamic ecosystem of universities, hospitals, venture capitalists, and government initiatives fuels this sector’s remarkable growth. In this Q3 2025 Investment Tracker, we spotlight newly funded UK start-ups pioneering breakthroughs in medical technology. Each has recently secured significant funding, translating into urgent hiring needs for scientists, engineers, clinicians, and business professionals alike. Whether you’re an experienced healthcare technologist or fresh from a biomedical engineering course, keep reading to uncover the latest trends, stand-out start-ups, and how to connect with them via MedicalTechnologyJobs.co.uk.