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