Regulatory Affairs Specialist / Manager

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