Regulatory Affairs Registration Specialist in Harrietsham

Salary, Location & Working Arrangements: £32,750 to £36,250 per annum. Position located in Harrietsham, Kent. The role offers hybrid working – three days per week in the Harrietsham office and up to two days from home once the candidate is deemed competent to work independently. Applicants must be UK‑based and live within a practical commuting distance of the office. Application deadline: 12th July 2026. 1st stage telephone interviews and second stage face‑to‑face interviews are scheduled during the last two weeks of July 2026.

About Bedfont: Established in 1976, Bedfont is an award‑winning medical technology company based in Harrietsham, Kent. Its breath analysis medical devices are exported worldwide through a network of carefully selected distributors.

The Challenge: Healthcare is evolving and the market for breath analysis monitors is expanding. Bedfont seeks hard‑working, like‑minded and passionate individuals to join the Bedfont Family and 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 licences including 510(k)s, Health Canada, NMPA registrations, licence variations and renewals.
• Monitoring and setting time frames for submissions for all new licence 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.
• Determining 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.
• Managing the pre‑screening process of registration requests through the pre‑approval process to capture vital regulatory requirements, associated costs, additional testing and sales forecast, and systematic screening of relevant entities, partners and products against applicable sanctions lists.
• Monitoring and advising on changes to legislation and suggesting appropriate actions.
• Ensuring compliance with applicable regulations, standards and guidance documents.
• Accountable for the preparation of responses to customers’ requests for information such as written regulatory affairs statements or questions.

Investigation Testing Authorisations (ITA’s):

• Detailed preparation and accurate submission of authorisation requests to the relevant regulatory bodies.
• Active management of timelines, conditions and approval requirements for each ITA.
• Monitoring ITA status and responding promptly to regulatory queries or requests for additional information.
• Preparing regulatory documentation for submission.
• Collaboration with internal and external stakeholders.

Qualifications: There are no specific formal qualifications or educational requirements for this role. However, candidates should be able to demonstrate the following knowledge, skills and experience:

• Experience working within a Regulatory Affairs environment, preferably within the medical device industry.
• Good knowledge and understanding of medical devices and their regulatory requirements.
• Experience preparing and submitting product registrations and regulatory submissions across multiple international markets.
• Experience leading or supporting regulatory development activities throughout the product lifecycle.
• Working knowledge of applicable regulatory and quality requirements, including ISO 13485, FDA QMSR and Health Canada regulations.
• Ability to interpret and apply regulatory requirements to support compliance, registrations and market access activities.

Valuable Expertise:

• A clear understanding and practical knowledge of preparing submissions for new licences.
• Confidence in compiling and maintaining regulatory documentation databases or systems.
• Strong verbal communication skills, with the ability to communicate effectively with regulatory authorities, notified bodies and internal stakeholders.
• Excellent written communication skills, including the preparation of technical and regulatory documentation.
• Knowledge of all applicable regulations (MDR, QMSR, MDSAP) and guidance to support pre‑market and post‑market requirements.
• Knowledge of medical device labelling requirements and standards, including UDI, ISO 15223‑1 and ISO 20417.

Additional Duties: In addition, employees may be required to undertake other duties as may reasonably be required of them. In these circumstances, training will be given where it is considered.

Equal Employment Opportunity: Bedfont® Scientific Ltd. does not and will not discriminate in the recruitment or management of staff on the basis of race, colour, religion, gender, age, disability, marital status, sexual orientation or any other protected characteristic. We are an equal opportunity employer, and Bedfont® regards every employee as a member of the Bedfont® family and is committed to providing a fair, safe, diverse and welcoming atmosphere. All successful candidates will be subject to a digital ID and DBS check.