Director of Regulatory Affairs

We\'re seeking a Director of Regulatory Affairs to join our Medical team. In this pivotal role, you\'ll provide strategic leadership and operational oversight for all regulatory activities, ensuring timely product approvals, maintaining compliance, and mitigating risks across the product lifecycle.

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• Lead and develop comprehensive global regulatory strategies for product development, registration, and post-market activities.
  
• Provide expert regulatory guidance and strategic input to project teams, assessing risks and proposing innovative solutions.
  
• Stay ahead of evolving regulatory landscapes (UK, EU, FDA) and effectively communicate their impact to stakeholders.
  
• Oversee the planning, coordination, and submission of major regulatory applications, managing the entire approval process and ongoing maintenance.
  
• Lead and manage a RAQA team, actively supporting their career growth and ensuring efficient team operations.
  
• Take overall responsibility for vigilance activities, including report submissions and responses to regulatory agency inquiries.
  
• Collaborate effectively with cross-functional departments to align regulatory strategies with business objectives.
  
• Communicate complex regulatory information clearly and effectively to diverse internal and external audiences.
  
• Extensive experience in regulatory affairs focused on IVDs or Software as a Medical Device or AI as a medical device.
  
• Proven track record of preparing and submitting regulatory documentation (e.g., US, EU, UK).
  
• Demonstrated experience in successful interactions and negotiations with regulatory authorities.
  
• Experience managing and developing regulatory teams.
  
• Deep and current knowledge of UK, EU, and FDA regulatory requirements and guidelines.
  
• Exceptional strategic thinking, leadership, and communication skills.
  
• Strong analytical and problem-solving abilities, with meticulous attention to detail.
  
• Excellent interpersonal skills, with the ability to build and maintain effective relationships.
  

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• Evidence thought leadership in a relevant area.
  
• Experience in both a large corporate and small business.
  
• Experience working in the wellness and health promotion space.
  

We\'re a pioneering health tech company on a mission to revolutionise the way we all understand and support our health. Our mission is simple: to help people, and their doctors, make better decisions that lead to longer, fuller lives. We focus on the common diseases that affect billions and the ones that put the greatest strain on our healthcare systems. By decoding the insights in our DNA, we\'re building cutting-edge tools and platforms that enable truly personalised medicine. Our vision is bold: a world where everyone benefits from genomics.

If you\'re inspired by the potential of cutting-edge science and technology and want to have a real impact on the future of healthcare, we\'d love to hear from you.

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• Salaries: Our salaries are externally benchmarked annually to ensure you receive compensation that aligns with the market.
  
• Holiday Allowance: 25 days of annual leave, an additional 3-day company shutdown at the end of the year, plus bank holidays.
  
• Progression: A straightforward and open progression framework to help you move up the career ladder.
  
• Invest in Your Future: Training and development opportunities, including access to a wide range of L&D materials.
  
• Hybrid Working: Choose between office and home work; based anywhere in the UK with regular office visits (generally at least twice a week).
  
• Wellbeing: Comprehensive health insurance for you and your family, critical illness coverage, life insurance, and enhanced paid family leave.
  
• Diversity and Inclusion: Bank Your Bank Holiday program to exchange public holidays for personal or cultural significance.
  
• Giving Made Easy: Payroll giving scheme for charitable donations.
  
• Green Commute: Cycle-to-work scheme; good access to public transport.
  
• Keeping it Social: Regular company events and activities throughout the year.
  

Genomics is dedicated to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Genomics politely requests no contact from recruitment agencies. We do not accept speculative CVs from recruitment agencies nor accept the fees associated with them.