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. What you’ll be doing Lead on the ongoing development and maintenance of associated regulatory policies covering feedback of health data, recontact studies, and potential Legal Manufacturer activities (SaMD, IVD) where applicable. Monitor post-Brexit UK MDR reforms, EU IVDR/MDR, and global regulatory trends and translate the implications of these changes into revised policy positions to support current and future Our Future Health initiatives. Lead on the development of regulatory policy papers and briefings and own the communication of regulatory policies throughout the organisation. Support and, where required, lead preparation of regulatory submissions and interactions with authorities. Work with internal stakeholders to establish necessary processes to support the regulatory strategy and associated regulatory obligations. Support the ongoing review of regulatory requirements for quality (e.g., ISO 13485, ISO 15189) and working with the Quality team to ensure these requirements are effectively and pragmatically implemented. Working with relevant subject matter experts or champions across Our Future Health and relevant Boards to help advise on regulatory issues. Support the Contract and Quality teams in ensuring supplier and partner compliance with applicable regulations and standards. Support the Head of Regulatory Affairs in interactions with MHRA, CQC, DHSC, and other authorities. Contribute to the ongoing development and maintenance of the regulatory aspects of our Participant Recontact Policy, and where required, provide support and guidance to 3rd party researchers with respect to their obligations under this policy and applicable UK Medical Device Regulations. Act as the primary point of contact for internal and external regulatory queries, triaging and escalating where appropriate. Build relationships with stakeholders and contribute to board-level progress reports. 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 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 – employer contributions of up to 12%. 30 Days Holiday + Bank Holidays. Enhanced Parental Leave. Cycle to Work Scheme. Home & Tech Savings – up to 8% off on IKEA and Currys products. £1,000 Employee Referral Bonus. Wellbeing Support – Mental Health First Aiders, 24/7 online GP services, and an Employee Assistance Programme. A Great Place to Work – flexible and remote working arrangements. Closing date for applications: 28th November at 12:00 noon. We recommend you apply as soon as possible as occasionally due to high volumes of applications, we need to close our postings early. At Our Future Health, we recognise the importance of having a diverse workforce and ensuring that all candidates, regardless of their background, have equitable access to our application process. We encourage applicants who identify as having a disability, neurodiversity, or long-term health conditions to let us know if they require any reasonable adjustments as part of their application process. If you do require any reasonable adjustments, please email us at talent@ourfuturehealth.org.uk. Join us – let’s prevent disease together. #J-18808-Ljbffr