Regulatory Affairs Specialist

Regulatory Affairs Specialist leading to RA Manager (Permanent) – Medical Devices

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 IIb consumer 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.

• 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.

• 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.

• 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.

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.

• 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 Josh@indoprofessionals.co.uk