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. It ensures Our Future Health remains credible with external regulators and able to make timely, pragmatic decisions that shape future organisational strategy.Despite big improvements in healthcare in our lifetimes, today millions of people in the UK still live in poor health as they get older. Diseases like cancer, dementia, diabetes, and heart disease affect the lives of many people in our communities. Our goal is to create a world-leading resource for health research, to improve our understanding and spot the patterns of how and why common diseases start, so treatments can begin sooner and be more effective.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.What you'll be doing:In this role you will work with the Head of Regulatory Affairs to develop regulatory pathways for the feedback of health information to participants under our Feedback, Engagement and Recontact Programme. Your key responsibilities will include but not be limited to: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 applicableMonitor 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 initiativesLead on the development of regulatory policy papers and briefings and own the communication of regulatory policies throughout the organisationSupport and, where required, lead preparation of regulatory submissions and interactions with authoritiesWork with internal stakeholders to establish necessary processes to support the regulatory strategy and associated regulatory obligationsSupport 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 implementedWorking with relevant subject matter experts or champions across Our Future Health and the relevant Boards to help advise on regulatory issuesSupport the Contract and Quality teams in ensuring supplier and partner compliance with applicable regulations and standardsSupport the Head of Regulatory Affairs in interactions with MHRA, CQC, DHSC, and other authoritiesContribute 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 RegulationsAct as the primary point of contact for internal and external regulatory queries, triaging and escalating where appropriateBuild relationships with stakeholders and contribute to board-level progress reportsRequirementsIdeally the successful candidate would have experience within the charitable, health, or research sectors. To succeed in this role, you will also have some of the following skills:Proven success in regulatory approvals in the UK/EU, particularly IVD or SaMDExperience developing regulatory policy in genetic testing or similarly novel areasStrong background in working with quality systems, specifically ISO 13485 and ISO 15189Experience 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 62366Strategic thinker with ability to dive into detailSkilled in cross-functional project leadershipExcellent written and verbal communication, able to prepare clear policy notes, internal papers, and regulatory submissionsStrong interpersonal skills, able to influence at all levelsSound judgement, able to balance risk, innovation, and pragmatismExperience of successful regulatory approvals for complex IVD WorkflowsFamiliarity with the UK DPA 2018, GDPR and ISO 27001Experience influencing regulatory policy at national or international levelBenefitsFrom £70,000 per annum basic salaryGenerous 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 youEnhanced Parental Leave - Supporting you during life's biggest momentsCycle to Work Scheme - Save 25-39% on a new bike and accessories through salary sacrificeHome & 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 familyA Great Place to Work - We have a lovely Central London office in Holborn, and offer flexible and remote working arrangementsJoin us - let's prevent disease together.Closing date for applications : 28th November at 12:00 noonWe 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 proactively 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