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Hybrid Regulatory Affairs Lead

at Our Future Health UK
Visit Our Future Health UK websiteVisit Our Future Health UK LinkedIn

Posted 6 days ago

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About the role

  • 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.
  • 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 the 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

  • Ideally the successful candidate would have experience within the charitable, health, or research sectors.
  • 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.

Job title

Regulatory Affairs Lead

Job type

Full Time

Experience level

Senior

Salary

£70,000 per year

Degree requirement

No Education Requirement

Location requirements

HybridLondonUnited Kingdom

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