Regulatory Affairs Manager /Senior Manager

Regulatory Manager (Permanent) – Medical Devices Leicester (Hybrid) – Office-based culture with flexibility (approx. 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. You’ll also support ongoing MDR transition work alongside an experienced Senior Regulatory Manager. Take responsibility for defining and executing global regulatory submissions while working closely with senior leadership.

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. Lead regulatory submissions and product registrations worldwide, ensuring compliant and timely approvals across Rest-of-World territories. 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. 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. • Collaborate across functions to ensure continued compliance and readiness for new product launches. 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. • 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.

You’ll be part of a well-established UK manufacturer known for quality and innovation in medical devices and consumer health products. They’re strengthening their compliance frameworks and expanding into new international markets. Hybrid working – typically three days in the Leicester office. • Real career growth potential within a respected UK medical device company.