At a Glance
- Tasks: Lead quality compliance and regulatory affairs for innovative healthcare software.
- Company: Join The Access Group, a leading UK software provider with a passion for better solutions.
- Benefits: Enjoy 25 days leave, health contributions, and flexible working options.
- Other info: Collaborative environment with opportunities for career growth and charity involvement.
- Why this job: Shape the future of healthcare tech while making a real impact on patient safety.
- Qualifications: Experience in medical device regulations and strong leadership skills.
The predicted salary is between 50000 - 65000 £ per year.
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.
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 giving you 25 days of 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.
Quality Compliance & Regulatory Affairs Manager in Loughborough employer: The Access Group
At Access, we pride ourselves on being an exceptional employer that fosters a collaborative and supportive work environment. With a strong commitment to employee development, we offer tailored career progression plans, generous wellbeing benefits including 25 days of leave and charity days, and the opportunity to work in a dynamic team that values quality and innovation in healthcare software. Join us in our mission to empower organisations while enjoying a fulfilling career in a thriving office culture.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Compliance & Regulatory Affairs Manager in Loughborough
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with potential colleagues on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their values and how they align with your passion for quality and patient safety. This will help you articulate how you can contribute to their mission during the interview.
✨Tip Number 3
Showcase your expertise! Bring examples of how you've successfully navigated regulatory challenges or improved quality management systems in past roles. This will demonstrate your ability to lead and make a real impact at Access.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of the Access family and contributing to our growth.
We think you need these skills to ace Quality Compliance & Regulatory Affairs Manager in Loughborough
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Quality Compliance & Regulatory Affairs Manager role. Highlight your experience with medical device regulations and how you can help us maintain our Quality Management System. Show us why you're the perfect fit!
Showcase Your Skills:Don’t just list your skills; demonstrate them! Use specific examples from your past experiences that relate to regulatory compliance and team leadership. We want to see how you’ve made a difference in previous roles, especially in a healthcare software environment.
Be Clear and Concise:When writing your application, clarity is key. Use straightforward language and structure your documents well. Remember, we’re looking for someone who can produce clear documentation for senior stakeholders, so show us you can do that right from the start!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about what we offer at Access!
How to prepare for a job interview at The Access Group
✨Understand the Regulatory Landscape
Before your interview, brush up on the latest regulations affecting software as a medical device. Familiarise yourself with UKCA and CE marking processes, as well as the role of the MHRA. This will show that you’re not just knowledgeable but also genuinely interested in how these regulations impact product success.
✨Showcase Your Leadership Skills
Be prepared to discuss your experience in leading teams and managing projects. Think of specific examples where you brought clarity to complex situations or helped teams understand regulatory requirements. Highlighting your ability to lead in a regulated environment will resonate well with the interviewers.
✨Prepare for Scenario-Based Questions
Expect questions that ask how you would handle specific compliance challenges or regulatory audits. Practice articulating your thought process and decision-making skills in these scenarios. This will demonstrate your practical understanding of quality management systems and your ability to think on your feet.
✨Connect with Their Values
Research Access Group’s mission and values, especially their commitment to quality and patient safety. During the interview, align your answers with their ethos of believing in better. Showing that you share their passion will help you stand out as a candidate who fits well within their culture.
