Regulatory Affairs Specialist / Manager
15 hours ago
Leicester
Regulatory Affairs Specialist leading to RA Manager (Permanent) – Medical Devices £50,000 - £60,000 per annum - applicants seeking more will also be considered Leicester (Hybrid) – Office-based culture with flexibility (around two days from home) Applicants must have the right to work in the UK; sponsorship or future sponsorship cannot be supported. Imagine joining a respected UK manufacturer whose products are trusted by consumers worldwide — where your regulatory expertise directly shapes how innovative medical devices reach new international markets. You’ll work across a broad portfolio of Class II medical devices, many of which are already well established across the UK and Europe, as the company expands further into Asia, Africa, and other Rest-of-World regions. Day to day, you’ll support MDR transition activities alongside an experienced Senior Regulatory Manager while taking increasing ownership of global product registrations and submissions. You’ll be part of a small, collaborative team that values initiative, open communication, and shared success. For someone ready to step up from a Regulatory Specialist or Associate role, this is a chance to take real ownership — and develop towards future leadership in a growing, well-resourced organisation. The Opportunity Global Reach: Lead and support product registrations across new markets, shaping regulatory pathways in Asia, Africa, and beyond. Strategic Involvement: Work closely with commercial teams to identify the most efficient routes to market and balance compliance with business objectives. Learning and Development: Gain exposure to end-to-end submissions while strengthening your understanding of MDR and international regulations. Collaboration and Impact: Partner with quality, manufacturing, and leadership teams to keep products compliant and ensure smooth, timely launches. Career Progression: Join at a point of expansion, with clear scope to grow into a managerial position and help guide the company’s global compliance strategy. How You’ll Make an Impact • Support and lead regulatory submissions and product registrations across Asia, Africa, and Rest-of-World markets., • Contribute to regulatory strategy and advise on cost, complexity, and timelines for new market entries., • Provide input on new product acquisitions and determine legal manufacturer or distributor responsibilities., • Support and mentor junior team members., • Contribute to MDR transition projects and ensure readiness for new product launches. The Kind of Person Who Will Thrive Here • Experienced in medical device regulatory affairs, ideally with exposure to multi-country submissions., • Strong understanding of EU MDR and its practical application., • A natural problem solver with a commercial mindset and an eye for process improvement., • Collaborative and adaptable, comfortable working in a smaller, hands-on environment., • Holds a scientific or technical degree (chemistry or related discipline preferred)., • Experience with sterile or cosmetic products would be a bonus, but medical device knowledge is key. Who You’ll Be Joining You’ll join a well-established UK manufacturer known for its quality, reliability, and innovation in medical devices and consumer health products. With around 100 employees across two sites, they combine the resources of a larger organisation with the friendly, agile culture of an SME. They’re investing in compliance and expanding globally — making this an exciting time to come on board. Why This Role Stands Out • Hybrid working – typically three days in the Leicester office., • Supportive, people-focused culture where everyone contributes., • A genuine opportunity to step into leadership and shape your career. Apply today or contact