Director of Regulatory Affairs

An exciting opportunity has arisen with a forward-thinking organisation operating in the digital health and medical device space. The business is seeking a Regulatory Manager to take a leading role in shaping and executing regulatory strategy across a portfolio of innovative digital medical technologies.

In this position, you will be responsible for defining and delivering regulatory strategies throughout the full product lifecycle, from early development through to post-market activities. You will ensure that regulatory risks, key challenges, and critical milestones are clearly communicated to project teams and stakeholders, acting as a trusted advisor across cross-functional groups.

Working closely with technical and clinical teams, you will provide clear and practical guidance on evolving global regulatory requirements for digital medical devices, supporting effective planning and informed decision-making. You will lead end-to-end submission activities, including planning, preparation, review, and coordination of global regulatory filings, ensuring all documentation meets applicable standards and timelines.

A key part of the role will involve collaborating with internal teams to define submission requirements, drive the delivery of supporting technical documentation, and ensure compliance with current regulatory frameworks. You will also take ownership of authoring and reviewing high-quality regulatory documents for health authority submissions, aligned with agreed strategies and global guidelines.

In addition, you will lead regulatory risk assessments, develop mitigation and contingency plans, and share insights and lessons learned from major submissions. Acting as a primary point of contact for health authority interactions, you will represent the organisation in global regulatory discussions.

This role also offers the opportunity to contribute to the wider regulatory function by mentoring colleagues, sharing expertise, and supporting the development of internal policies, processes, and best practices within digital medical device regulation.