Director of Regulatory Affairs

Genomics; Oxford; Hybrid; GBP 70,000 - 100,000; Full time

Job summary

A leading health tech company seeks a Director of Regulatory Affairs to provide strategic leadership for regulatory activities. This role involves ensuring compliance, managing a team, and overseeing the regulatory lifecycle. Candidates should possess extensive experience in regulatory affairs, particularly with IVDs or Software as a Medical Device, and demonstrate strong leadership and communication skills.

Benefits

25 days annual leave plus bank holidays

Health insurance for you and your family

Training and development opportunities

Hybrid working options

Company socials and team events

Qualifications

• Extensive experience in regulatory affairs focused on IVDs/Software as a Medical Device.
• Proven track record of preparing and submitting regulatory documentation.
• Deep knowledge of UK, EU, and FDA requirements.

Responsibilities

• Lead global regulatory strategies for product development and approvals.
• Oversee regulatory compliance and risk mitigation.
• Manage and develop a Regulatory Affairs and Quality Assurance team.

Skills

Strategic thinking

Leadership

Communication

Problem-solving

Education

Degree in relevant field (e.g., Life Sciences, Regulatory Affairs)

Job description

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Location: Cambridge, Oxford, or London (Hybrid, minimum 2 days per week in office)

About Us

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, the ones that put the greatest strain on our healthcare systems.

Each person is unique, and by decoding the insights in our DNA, we’re building cutting-edge tools and platforms that enable truly personalised medicine. From prevention and early screening, to diagnosis, treatment, and even the development of new medicines, there is so much more to discover and build to support people at each step of their healthcare journey.

With our leading science and brilliant partners, we can make healthcare smarter, more precise, and more personal. 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.

A Day in the Life

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

What you'll do:

• 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.
  
  

What you'll bring:

• Extensive experience in regulatory affairs focussed 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
  
  

Non-essential Criteria

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

So what's in it for you?

• 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. More time for you to unwind and enjoy.
• Progression - We've got a straightforward and open progression framework that lets you easily see your strengths and areas where you can improve. With this knowledge, you can set personal goals to help you move up the career ladder.
• Invest in Your Future: Take advantage of our training and development opportunities. From regular training courses, to access to a wide range of L&D materials. We're committed to helping you grow and succeed!
• Hybrid Working: Tailored to You: Choose between working in the office and from home. You can be based anywhere in the UK as long as you can get to any one of our offices regularly. As a guide, we expect people to come to the office at least twice a week.
• Wellbeing: Join a company that values you not just at work but also outside work. We offer a range of benefits, including comprehensive health insurance for you and your family, critical illness coverage, and life insurance. We also offer enhanced paid family leave.
• Diversity and Inclusion -We offer our 'Bank Your Bank Holiday' program, allowing you to exchange public holidays for dates that hold personal or cultural significance to you. It's our way of ensuring that every member of our community feels valued and included.
• Giving Made Easy: Make a difference with our payroll giving scheme. Donate to your favourite charities tax-free and help make the world a better place!
• Green Commute: Join our cycle-to-work scheme and enjoy a healthier, eco-friendly commute. We are also conveniently located by major transport hubs so public transport is a snip. It's good for you and the planet!
• Keeping it social: There are a variety of company socials to enjoy throughout the year, from regular company town halls, team picnics, outdoor summer activities, sports events, and other events organised by our social committee.
  
  

Would you like to learn more? Great, we’d love to chat. Please reach out for more information and to see if this opportunity is right for you!

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.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

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