Senior Regulatory Specialist



Cambridge, UK · Oxford, UK
Posted on Wednesday, September 27, 2023
Location: Oxford or Cambridge ~ 20-40% with the rest remote working
About Us
We're a pioneering health tech company that aims to revolutionise the future of healthcare . We're all about enhancing the patient journey, particularly for those common diseases that affect most people and take up most of our precious healthcare resources.
Our secret weapon? Genomics! We use it to power our tools and systems, improving every step of the patient pathway. From preventing diseases to screening, diagnosing, treating, and even developing new medicines - we've got it covered.
But we're not stopping there. Our vision is a world where everyone benefits from our genomic technology, helping folks and entire populations to live longer, healthier lives. We have made it into the Newsweek list of the UK’s 100 Most Loved Workplaces 2023 as well as one of Bloomberg's top 25 UK Startups to Watch.
So, if that all sounds exciting, come join us!
A Day in the Life
A typical day will be varied and interesting. You'll lead the way in product design and development, working closely with our software teams to ensure that we meet all compliance standards. Working closely with different teams to keep us on the right side of regulations, you will be a guiding force to ensure that our policies and procedures match the wider businesses. On top of this, you will also have involvement in helping to shape our exciting future strategies within a company that thrives on innovation. In essence, you will be a guiding force behind Genomics' regulatory journey, where compliance meets innovation.
Regulatory compliance is vital for Genomics success and you will have a significant impact in achieving it!

Who You Are

  • Navigating the Medical Device Software Seas: Vast experience in managing and documenting medical device software regulatory requirements, ensuring compliance with industry standards.
  • IEC 62304 Expertise: A seasoned professional with comprehensive knowledge and hands-on experience in the application of IEC 62304 standards.
  • Navigating Regulatory Waters Globally: Seasoned in medical device and IVD regulatory submissions in at least one of the following regions: UK, EU, or USA, and well-versed in the nuances of each.
  • Mastery of Regulatory Writing: Proficient in the art of crafting clear, concise, and compelling written and verbal communications, bringing complex regulatory matters to life.
  • Unleashing Creativity and Innovation: A natural problem solver with a knack for innovative solutions, adding a touch of creativity to regulatory processes.
  • A true collaboration champion: We need someone who effortlessly bridges gaps between teams, can simplify intricate concepts, and enjoys tackling problems with a proactive approach.

What's in it for you?

  • Salaries: Our salaries are externally benchmarked annually to ensure you receive compensation that aligns with the market.
  • Stock options: Every team member gets stock options ensuring that everyone reaps the rewards of our collective growth.
  • Generous 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 1-2 times 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 - At Genomics, we wholeheartedly embrace and champion Diversity and Inclusion (D&I) initiatives. We foster an inclusive environment through various means, such as our 'All in Club,' a platform where we come together to celebrate and engage in meaningful discussions about cultural diversity. Additionally, 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 plc 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 plc politely requests no contact from recruitment agencies. We do not accept speculative CVs from recruitment agencies nor accept the fees associated with them.