Regulatory Affairs Registration Specialist

Salary: £32,750 to £36,250

Location:

Harrietsham, Kent Application and Interviews The job advert closes by the 12th July 2026, with 1st stage telephone interviews and second stage face-to-face interviews scheduled to be held during the last two weeks of July 2026. Hybrid Working Opportunity This role is eligible for the hybrid working benefit, requiring the successful candidate to attend our Harrietsham office three days per week, with the flexibility to work from home up to two days a week once deemed competent to work independently and in line with the business needs.

Applicants must be UK-based and live within a practical commutable distance of our office. Hybrid working is a benefit at Bedfont and not a contractual term. The Story:
Established in 1976, Bedfont is an award-winning medical technology company based in Harrietsham, Kent. Its breath analysis medical devices are exported globally thanks to its network of carefully selected distributors. The Challenge:
Healthcare is evolving and the market for breath analysis monitors is expanding. Bedfont are looking for hard-working, like-minded, and passionate individuals to join the Bedfont Family to help achieve its goal of innovating healthcare worldwide. The Benefits: 25 days paid holiday plus bank holidays Social events Private medical insurance Subsidised health checks Well-being warriors Well-being garden and room Annual optical allowance Cycle to work scheme Pension scheme Bonus scheme Hybrid working Employee Assistance Programme (EAP) Rewards and discounts platform Referral bonus Charity days Home office setup allowance Employee awards Free on-site parking Training & development opportunities Free uniform Subsidised kids club Subsidised Celler8 Devices Time in service annual leave bonus Enhanced Maternity and Paternity Pay Your Mission:
The Regulatory Affairs Registration Specialist is responsible for managing and coordinating regulatory registration activities to support the compliance and market access of Bedfont's products worldwide. The role acts as a key liaison between regulatory authorities, distributors, notified bodies, consultants and internal stakeholders, ensuring that regulatory requirements are met and maintained throughout the product lifecycle. The primary focus of the role is the preparation, submission and maintenance of product registrations, licences and regulatory approvals across global markets.

The position requires a strong understanding of medical device regulatory requirements and the ability to manage multiple projects, priorities and stakeholder relationships simultaneously. The Regulatory Affairs Registration Specialist will work closely with cross-functional teams to support regulatory strategies, maintain compliance with applicable regulations and standards, and ensure regulatory activities are delivered efficiently and effectively to support business objectives. Strong communication, organisational and relationship management skills are essential to successfully coordinate activities with both internal and external stakeholders.

Roles and Responsibilities:

Applying for worldwide registrations. Preparing submissions for new licenses including 510ks, Health Canada, NMPA Registrations, license variations and renewals. Monitoring and setting time frames for submissions for all new license applications. Keeping up to date with global legislation, applicable regulations, relevant standards and customer practices in all countries. Responsible for compiling and maintaining regulatory documentation databases and systems. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labelling changes.

Responding to additional requests from regulatory bodies. Providing internal support and guidance to the business by meeting internal/external requirements. Manage the pre-screening process of Registration requests through the pre-approval process to capture vital regulatory requirements, associated costs, additional testing and sales forecast. Systematic screening of relevant entities, partners, and products against applicable sanctions…