Quality Assurance and Regulatory Affairs Manager (QA/RA)

Permanent employee, Full-time · Cambridge

Job Summary
​We are looking for a Quality Assurance and Regulatory Affairs Manager (QA/RA) who has a passion and expertise in scientific, legal, and business issues to ensure products, which are developed, manufactured, and deployed meet applicable legislations. You will play a crucial link between Cyted cross-functional teams (including the lab), the products and regulatory authorities, taking responsibility of clinical, regulatory, and compliance for IVD and Medical Device product life cycle, ensuring variety within the role.
Working Pattern and Location
​The role is a full-time position with a standard 37.5 hour working week. The role holder may be required to work flexibly.

You will be based at both the Cyted’s Head Office, 22 Station Road, Cambridge, United Kingdom, CB1 2JD and Cyted’s Laboratory 2 Falcon Road, Hinchingbrooke Business Park, Huntingdon, Cambridgeshire, United Kingdom, PE29 6FG, with the flexibility to work from home on an as needed basis. 

We actively encourage travel and working from our other business sites to ensure you get to meet the team and understand what the different areas of the business do. We will support you with transport if required.
What you will be doing
  • Use your expertise in scientific, legal, and business issues to support products current in development and marketed, from reviewing design changes, labelling, and promotional material, to changes requiring regulatory agency approval, as pertains to UK, EU and US and international regulatory requirements.
  • Manage submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.
  • As a growing business, you will ensure overall compliance with international standards and directives, which lead to and maintain international regulatory approval to market devices.
  • Manage the document controller in the creation and review of Standard Operating Procedures and policy guidelines related to quality and regulatory affairs.
  • Lead and assist internal and external audits to ensure compliance to external regulatory requirements and continuous improvement. 
How we work
  • Our team works in an agile working environment, where everyone’s ideas and opinions are valued. Have a better way of carrying out a process, we want to hear from you!
  • We value user engagement
  • We are committed to quality with a strong testing culture
  • We work across both our sites to collaborate with all teams
Person Specification
  • To succeed in this role, you will need established quality experience (minimum 5 years or equivalent) in IVD/Medical Device industry
  • You have experience in CE-IVD and 510K submissions
  • You are resourceful
  • You are curious
  • You can demonstrate initiative
  • You are not afraid to try new things
  • You can empathise with users
  • You enjoy solving problems
  • Salary in the range of £40,000 to £60,000 per annum depending on skills and experience.
  • 25 days holiday per holiday year, plus public holidays
  • Pension scheme
  • An annual learning and development budget
  • Medical insurance including dental and optical cover
  • Life/critical illness cover
  • Social events including Christmas and Summer parties
  • Cycle to work scheme
  • Electric Vehicle Scheme
  • Sabbatical 4 years of service
About us

Our mission is to revolutionise diagnostic methods to build a world where disease is prevented rather than treated. We focus on providing digital diagnostic infrastructure to drive the earlier detection of disease. Our technologies use artificial intelligence and novel biomarkers to unlock clinical insight and improve patient outcomes.

We develop and deploy digital diagnostic services for research and clinical use. Our services are designed to dignify and empower, placing patients at the heart of our services.

We are committed to inclusion and diversity and believe that having a team that reflects a broad range of experiences and perspectives will help us build software that is intuitive for our users (administrators, scientists, pathologist, doctors and nurses) and leads to the best outcomes for patients. We especially encourage applications from people who are underrepresented in the software sector and/or who have non-traditional education or career experiences.

We interview on a rolling basis, starting with a brief call to discuss what we're doing and whether it resonates with you.

We are looking forward to hearing from you!
Thank you for your interest in a role at Cyted. Please fill out the following short form. Should you have difficulties with the upload of your data, please send an email to careers@cyted.ai.

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