We are looking for a Head of Regulatory Affairs who will be responsible for refining and implementing our regulatory strategy with regards to research use only, in-vitro diagnostics and medical devices, in the context of our feedback and recontact initiatives.

Our Future Health will be the UK’s largest ever health research programme, bringing people together to develop new ways to detect, prevent and treat diseases. We are a charity, supported by the UK Government, in partnership with charities and industry. We work closely with the NHS and with public authorities across all nations and regions of the UK.

Our plan is to bring together 5 million volunteers from right across the UK who will be asked to contribute information to help build one of the most detailed pictures we have ever had of people’s health. Researchers will be able to use this information to make new discoveries about human health and diseases. So future generations can live in good health for longer.

What you’ll be doing

The Head of Regulatory Affairs will be responsible for the provision of an efficient and proactive regulatory service to meet the business objectives and deadlines for Our Future Health. In this role, your key responsibilities will include but not be limited to:

Strategise for Success: Lead the implementation of regulatory strategies tailored to in-vitro diagnostics and medical devices.

Quality Collaboration: Work closely with the Compliance and Quality teams to refine and implement a robust Quality Management System.

Compliance Mastery: Ensure alignment with UK regulatory bodies and swiftly adapt strategies to regulatory changes.

Regulatory Submissions Expertise: Focus on regulatory submissions and work with Compliance and Quality teams to ensure high quality standards.

Stakeholder Engagement: Manage relationships with external stakeholders, being the go-to regulatory contact.

Team Leadership: Support executive directors and cultivate a collaborative team environment.

Requirements

To succeed, you will have some of the following skills and experience:

Experience Required:

Regulatory Acumen: Proven experience in securing UK/EU regulatory approvals, especially for In Vitro Diagnostics and Software as a Medical Device, utilising genetic data.
Strategic Expertise: Proficiency in crafting and executing complex regulatory strategies with high-level reporting experience.
Sector Experience: Background in health, research, or charitable sectors, ideally in start-up environments.
Quality Systems Knowledge: Well-versed in ISO13485, ISO 14971, IEC 62304, and IEC 62366.
Regulatory Interaction: Familiarity with liaising with external regulatory authorities.

Skills Summary:

Strategic and Detail-Oriented: Adept at developing detailed regulatory strategies.
Cross-functional Leadership: Skilled in managing diverse projects and analysing scientific/technical information.
Organisational Prowess: Exceptional organisational skills, juggling multiple projects and meeting tight deadlines.
Resourceful and Proactive: Efficient under resource constraints, driving change effectively.
Project Management Expert: Excellent at time management and prioritisation.
Confidentiality and Compliance: Discretion in handling sensitive information, knowledgeable in ISO 27001 and GDPR/DPA 2018.
Healthcare Passion: Committed to making a significant impact in healthcare and research.

Benefits

• Up to £80,000 per annum basic salary.
• Generous company pension package with employer contributions of up to 12%.
• 30 days annual leave (plus bank holidays.)
• Continuous career development with regular appraisals and learning and development opportunities.
• A lovely new office in Holborn, Central London – we offer flexible and remote working arrangements.

Join us - let’s prevent disease together.