🚀 Regulatory Affairs Manager

Regulatory Manager (Permanent) – Medical Devices Leicester (Hybrid) – Office-based culture with flexibility (approx. two days from home) Applicants must have the right to work; sponsorship / future sponsorship cannot be supported. This is an opportunity to step into a visible, commercially connected Regulatory role where you’ll shape market expansion for a leading UK manufacturer of Class IIb medical devices . You’ll join a company with a diverse portfolio of consumer medical products sold through major high-street retailers and international partners. The business is privately owned, well-resourced, and operates with the spirit of an SME. Due to steady growth, they are creating a new position to take the lead on global product registrations and drive market access across Asia, Africa, and other Rest-of-World regions . You’ll also support ongoing MDR transition work alongside an experienced Senior Regulatory Manager. The Opportunity Visibility and Ownership: Take responsibility for defining and executing global regulatory submissions while working closely with senior leadership. Strategic Input: Work with the commercial team to decide the most effective route to market — whether to register products via local distributors or retain legal manufacturer responsibility directly. Market Expansion: Lead regulatory submissions and product registrations worldwide, ensuring compliant and timely approvals across Rest-of-World territories. Collaboration: Partner with quality, manufacturing, and commercial teams to maintain compliance and enable new launches. Career Growth: Join at a time of expansion, with scope to progress towards the Head of Compliance role in the medium term. Culture and Flexibility: Enjoy an open, down-to-earth working environment with genuine flexibility. How You’ll Make an Impact • Lead regulatory submissions and product registrations across Asia, Africa, and other Rest-of-World markets. • Advise on market entry strategy, helping assess regulatory complexity, cost, and timelines. • Provide regulatory input for new product acquisitions, determining legal manufacturer and distributor responsibilities. • Manage and support two Regulatory Associates. • Contribute to MDR transition work where required. • Collaborate across functions to ensure continued compliance and readiness for new product launches. Who Will Thrive Here • Experienced in medical device regulatory affairs , with multi-country registration experience . • Commercially minded with the ability to balance compliance requirements with business goals. • Skilled at building relationships and influencing cross-functional teams. • Enjoys working in smaller, collaborative settings where responsibilities are broad and shared. • Holds a scientific or technical degree (chemistry or related discipline preferred). • Experience with sterile products or cosmetics is a plus, but medical devices expertise is key. Who You’ll Be Joining You’ll be part of a well-established UK manufacturer known for quality and innovation in medical devices and consumer health products. With around 100 employees across two sites, the company combines the stability of a larger organisation with the agility and informality of a smaller team . They’re strengthening their compliance frameworks and expanding into new international markets. Collaboration, flexibility, and mutual support are at the heart of how they work. Why This Role Stands Out • Hybrid working – typically three days in the Leicester office. • Supportive, people-focused culture where everyone contributes. • Real career growth potential within a respected UK medical device company. Apply today or contact