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Quality compliance & regulatory affairs manager

Loughborough
Regulatory affairs manager
Posted: 13h ago
Offer description

We’re looking for people to join the Access family, who share our passion for believing in better, and who will help us continue to grow. Love Work. Love Life. Be You. - is central to our success and how we give our customers the freedom to do more of what's important to them. What does Access offer you? We offer a blended approach to office working, encouraging you to collaborate and connect in one of our thriving offices. We deliver on what we say, taking the development of our people seriously. We’ll work with you to progress your success plan and provide opportunities to accelerate your career. On top of a competitive salary, our wellbeing days taking you to 25 days leave a year and a health contribution, you’ll also be able to choose from a range of benefits to suit you. We’re an organisation that likes to give back, so you’ll also have three charity days allocated to support a cause that matters to you. About you: You like making sense of complex rules and turning them into practical ways of working. You care about quality, patient safety and doing the right thing, but you also understand that great governance should help products succeed, not slow them down. You’re comfortable working across teams like product, engineering and clinical, and you’re confident engaging with regulators and auditors. You enjoy leading others, bringing clarity to uncertainty, and helping teams understand what good looks like in a regulated healthcare software environment. At Access, you’ll help shape how we build trust with customers and regulators as our products continue to evolve. Day to day, you will: Lead and maintain our medical device Quality Management System, making sure it’s practical, understood and supports how teams actually work. Own regulatory compliance for our health and care software products, including technical files, UKCA and CE marking, and engagement with the Medicines and Healthcare products Regulatory Agency (MHRA). Run post‑market surveillance and vigilance activities, using real customer and safety data to identify risks and drive improvements. Manage and develop a small specialist team, while working closely with product, clinical safety and engineering to embed quality and regulatory thinking early. Your skills and experiences might also include: Experience working with software as a medical device and understanding how regulations apply to digital health products. Exposure to emerging areas like artificial intelligence in healthcare and how this changes regulatory expectations. Experience preparing for or supporting external audits and certifications such as ISO 13485 or ISO 9001. Confidence producing clear, well‑structured documentation for senior stakeholders, auditors and regulators. What are we all about? The Access Group is one of the largest UK-headquartered business management software providers. It provides solutions that empower more than 160,000 small and mid-sized organisations in commercial and non-profit sectors across Europe, USA and APAC, giving every employee the freedom to do more of what's important. Its innovative cloud solutions and integrated AI software experience across multiple Access products transform how business technology is used. With over 9,300 talented individuals driving innovation and customer excellence, we’re shaping the future of work. And we want you to be part of it. At Access, people are at the heart of everything we do. We’re committed to creating an inclusive, high-performing culture where everyone feels valued, respected, and empowered to thrive. If you’re excited about this role - even if your experience doesn’t tick every box - you might be exactly who we’re looking for. We believe in equality for all and the transformative power of diversity. So why not join our vibrant team, where you can love what you do, love how you live, and most importantly, be authentically you? Let’s make a difference together. Love Work. Love Life. Be You.

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