Regulatory Affairs & Market Access Coordinator (12-month contract maternity cover)

About the Role

We are seeking an organised, proactive and detail-oriented Coordinator to join our team on a 12-month fixed-term contract to provide maternity cover. The individual must have experience of regulatory affairs within a medical devices environment.

This is a part-time position of 20 hours per week, with a high degree of flexibility. We are happy to discuss working days, hours, working patterns and location to find an arrangement that suits the successful candidate while meeting the needs of the business.

The successful candidate will play an important role in supporting the company's regulatory, clinical and commercial activities, ensuring that information, documentation and records are maintained accurately and in accordance with relevant requirements.

The position involves liaising with regulatory authorities, NHS organisations, external partners and internal teams, as well as supporting commercial projects.

This is a varied role suited to someone with excellent organisational skills, strong attention to detail and the ability to manage multiple responsibilities independently.

Key Responsibilities

Regulatory Affairs & Compliance

Maintain accurate regulatory records, documentation and statutory notifications, ensuring information is kept up to date.

Coordinate regulatory submissions, notifications and ongoing record maintenance with relevant authorities and organisations, including:

• Medicines and Healthcare products Regulatory Agency (MHRA), including MORE portal management and submissions
• NHS and NHS Supply Chain
• Jaggaer portal

Liaise with external information and regulatory bodies, including MIMS, BNF, PPA/Drug Tariff and C&D Data

Coordinate the annual update of the NHS Supply Chain MIA Register, including completion and submission of the required documentation and supporting insurance information

Maintain accurate and accessible compliance records, ensuring relevant deadlines and requirements are met

Clinical & Commercial Support

Support the preparation and submission of NHS customer agreements and associated documentation

Assist with formulary applications, ensuring relevant clinical and product information is accurate and up to date

Work with internal teams to ensure sales materials are standardised and reflect the latest available clinical evidence

Support the marketing team in developing and updating promotional and educational materials using current, relevant clinical information

Help ensure consistency and accuracy across clinical, regulatory and commercial documentation

Stakeholder & Partner Coordination

Act as a point of contact for relevant external organisations, regulatory bodies and healthcare stakeholders

Support effective communication and information sharing between internal departments and external partners

Assist in coordinating documentation, updates and administrative requirements relating to partner activities

Administration & Business Support

Provide administrative and coordination support across regulatory, clinical and commercial activities

Maintain organised electronic records and documentation to support efficient information retrieval and reporting

Undertake other reasonable duties appropriate to the role, depending on business requirements

Person Specification

Essential Skills & Experience

Previous experience in an administrative, coordination or support role, ideally within the healthcare, pharmaceutical, medical device or life sciences sector

Excellent organisational skills, with the ability to prioritise tasks and manage competing deadlines

High level of accuracy and attention to detail, particularly when maintaining records and preparing documentation

Strong written and verbal communication skills, with confidence liaising with internal and external stakeholders

Good IT skills, including proficiency in Microsoft Office applications, particularly Word, Excel and Outlook

Ability to work independently, use initiative and take ownership of assigned responsibilities

A flexible, proactive and collaborative approach to work

Ability to handle confidential and commercially sensitive information appropriately

Applicants must have the legal right to work in the UK

Desirable Skills & Experience

Experience working within the UK healthcare, pharmaceutical or medical device industry

Familiarity with MHRA requirements, regulatory documentation or compliance processes

Previous experience dealing with NHS organisations, NHS Supply Chain or healthcare procurement systems

Familiarity with formulary applications, healthcare product listings or regulatory submission portals

Flexible Working Arrangements

We recognise the importance of work-life balance and understand that flexibility can make a real difference.

This position is offered on a 12-month fixed-term contract (maternity cover), working 20 hours per week.

We are happy to offer flexibility around:

• Working days: The 20 hours can be spread across the week in a way that suits the successful candidate
• Working hours: We are open to discussing start and finish times
• Working pattern: We welcome applications from candidates seeking different part-time working arrangements
• Working location: We are flexible regarding where the successful candidate is based and are happy to discuss suitable remote, hybrid or office-based arrangements

Our aim is to agree a working arrangement that works well for both the individual and the business

About You

You will be a highly organised and dependable individual who enjoys working in a varied role and supporting different areas of a business.

You will be comfortable managing detailed information, communicating with a range of stakeholders and ensuring that important administrative and regulatory activities are completed accurately and on time.

Experience within healthcare or medical devices would be advantageous, but equally important are your ability to learn, attention to detail and willingness to take a proactive approach.

Eligibility to Work

All applicants must have the legal right to work in the United Kingdom and be able to provide appropriate evidence of their right to work prior to commencing employment.

This job description provides an overview of the principal responsibilities of the position and is not intended to be exhaustive. Duties may be amended from time to time to reflect the changing needs of the business, in consultation with the postholder.