Regulatory Affairs Lead

We have an exciting opportunity for a Regulatory Affairs Lead to join our Ethics, Compliance and Governance department. This role is vital to Our Future Health’s ability to deliver participant feedback and recontact studies within a complex regulatory environment.

Requirements

• Proven success in regulatory approvals in the UK/EU, particularly IVD or SaMD.
• Experience developing regulatory policy in genetic testing or similarly novel areas.
• Strong background in working with quality systems, specifically ISO 13485 and ISO 15189.
• Experience of engaging directly with regulatory agencies (MHRA, CQC).
• Broad experience of a wide range of standards including (but not limited to) ISO 13485, ISO 15189, ISO 14971, IEC 62304, and IEC 62366.
• Strategic thinker with ability to dive into detail.
• Skilled in cross-functional project leadership.
• Excellent written and verbal communication, able to prepare clear policy notes, internal papers, and regulatory submissions.
• Strong interpersonal skills, able to influence at all levels.
• Sound judgement, able to balance risk, innovation, and pragmatism.
• Experience of successful regulatory approvals for complex IVD Workflows.
• Familiarity with the UK DPA 2018, GDPR and ISO 27001.
• Experience influencing regulatory policy at national or international level.

Benefits

• From £70,000 per annum basic salary.
• Generous Pension Scheme – We invest in your future with employer contributions of up to 12%.
• 30 Days Holiday + Bank Holidays – Enjoy a generous holiday allowance with the flexibility to take bank holidays when it suits you.
• Enhanced Parental Leave – Supporting you during life’s biggest moments.
• Cycle to Work Scheme – Save 25-39% on a new bike and accessories through salary sacrifice.
• Home & Tech Savings – Get up to 8% off on IKEA and Currys products, spreading the cost over 12 months through salary sacrifice.
• £1,000 Employee Referral Bonus – Know someone amazing? Get rewarded for bringing them on board!
• Wellbeing Support – Access to Mental Health First Aiders, plus 24/7 online GP services and an Employee Assistance Programme for you and your family.
• A Great Place to Work – We have a lovely Central London office in Holborn, and offer flexible and remote working arrangements.