Regulatory Affairs Specialist

2 weeks ago

England, United Kingdom Indo Search Full time

Regulatory Consultant – Permanent - Remote - SaMD/AISaMD and AI FocusFully Remote UK (or Ireland) - must be residing in the UK (or Ireland) Circa £85,000 per annum, depending on experience, with flexibility for a SaMD expert. If you have hands-on regulatory experience with software-based medical devices and you enjoy working directly with engineering teams, this role is likely to suit you.The consultancy supports AI researchers, early spinouts and scaling digital health companies across the UK, Ireland and the EU. They need someone confident in determining software and AI product classification, shaping early regulatory strategy and guiding clients through documentation and submissions.You will work remotely from either the UK or Ireland and will be the regulatory lead for a variety of clients developing SaMD and AI-driven products.You should be comfortable with IEC 62304/SaMD aligned documentation, software lifecycle requirements, technical file preparation and regulatory expectations for AI models entering regulated pathways.If you are looking to deepen your technical expertise in SaMD and build exposure to the latest digital health technologies, you will thrive here.What You Will DoGuide clients through the classification of software and AI based products for MDR, IVDR and FDA.Shape regulatory strategies for early-stage development and market entry.Prepare and review technical documentation and artefacts aligned to 62304 and wider SaMD expectations.Support design reviews, risk management and clinical evaluation planning.Advise founders, product teams and engineering groups on regulatory best practices throughout the development lifecycle.What You Will BringProven regulatory affairs experience within software, SaMD or digital health.A clear understanding of MDR, IVDR and FDA 510k requirements.Strong familiarity with 62304, software lifecycle processes and technical documentation.Confidence working directly with software, ML and engineering teams.An interest in deepening your knowledge of AI and software-based regulation.An organised, practical communication style that helps clients move forward.Who You Will Be JoiningA long-established regulatory consultancy with a strong reputation in the SaMD and digital health sector.Their clients range from academic researchers spinning out for the first time to scaling startups building complex AI-driven devices.The team is small, collaborative and highly knowledgeable, and you will have plenty of support as you take ownership of your own projects.The structure gives you significant variety, responsibility and the chance to grow your expertise in one of the most innovative areas of MedTech.Please apply today or contact Josh@indoprofessionals.co.uk for more information

  • Regulatory Affairs Specialist

    2 weeks ago

    Newquay, England, United Kingdom Cytiva Full time £40,000 - £70,000 per year

    Be part of something altogether life-changingWorking at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.At Cytiva you will be able to...

  • Regulatory Affairs Specialist

    5 days ago

    England, United Kingdom Indo Search Full time

    Regulatory Consultant – Permanent - Remote - SaMD/AI SaMD and AI Focus Fully Remote UK (or Ireland) - must be residing in the UK (or Ireland) Circa £85,000 per annum, depending on experience, with flexibility for a SaMD expert. If you have hands-on regulatory experience with software-based medical devices and you enjoy working directly with engineering...

  • Senior Regulatory Affairs Officer

    2 weeks ago

    South East England, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

    You will be responsible for: - Liaising with both internal and external stakeholders to ensure all regulatory requirements are met. - Co-ordinating and submitting PSURs and preparing responses to questions from Regulatory Authorities. - Monitoring product safety information, maintaining product labelling and reviewing artworks for use in submissions. - At...

  • Senior Director, Regulatory Affairs

    6 days ago

    York Wy, England, N AS United Kingdom Inc Full time

    Join Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a...

  • HR Regulatory Affairs Associate

    1 week ago

    City Of London, England, United Kingdom J.P. Morgan Full time £60,000 - £120,000 per year

    HR Regulatory Affairs Associate - JP Morgan - London - 12 months contract - ONSITE - PAYEWe are seeking an HR Regulatory Affairs Associate with banking regulations experience to join JP Morgan on an initial 12 months maternity cover contract in London.Join the team that works on Human Resources (HR) aspects of regulatory initiatives impacting the firm's...

  • HR Regulatory Affairs Associate

    6 days ago

    City Of London, England, United Kingdom Robert Walters Full time

    HR Regulatory Affairs Associate - JP Morgan - London - 12 months contract - ONSITE - PAYEWe are seeking an HR Regulatory Affairs Associate with banking regulations experience to join JP Morgan on an initial 12 months maternity cover contract in London.Join the team that works on Human Resources (HR) aspects of regulatory initiatives impacting the firm's...

  • Regulatory Specialist

    1 week ago

    Hertfordshire, England, United Kingdom Zest Scientific Recruitment Full time £45,000 - £75,000 per year

    Zest Scientific is recruiting a Regulatory Specialist for one of the most recognisable names in the pharmaceutical sector, boasting an enviable portfolio across an impressive therapeutic range.You are a passionate regulatory expert with a clear vision for improving patient outcomes. Leveraging your broad and comprehensive expertise in the UK regulatory...

  • Senior Manager Regulatory Affairs

    6 days ago

    Uxbridge, England, United Kingdom PE Global Full time

    PE Global are currently recruiting for a Regulatory Affairs Manager (CTA) with EU experience for an initial 12 month contract role with a leading multinational Pharma client based in either Uxbridge or Cambridge - 1 day per month in the office.You will be working with colleagues who are responsible for leading the European regulatory strategies and...

  • Regulatory Affairs Associate

    1 week ago

    North West, England, United Kingdom Dechra Full time £40,000 - £70,000 per year

    Job IntroductionThanks for checking out our vacancy, we're delighted you want to learn more about DechraDechra are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.Here at Dechra, our values are...

  • EU Regulatory Affairs Senior Manager

    4 days ago

    Uxbridge, England, United Kingdom Amgen Full time

    HOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing and delivering ever-better...