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Regulatory Affairs Manager

London, England

Company Description

Genomics England successfully led the world-leading 100,000 Genomes Project, which compared and analysed individuals’ genetic codes to help diagnose, treat and prevent illness.

We're now accelerating our impact, working with the NHS to further develop and embed genomic healthcare and research in Britain. Our next chapter involves working with patients, doctors, scientists, government and industry to improve genomic testing, and help researchers access the health data and technology they need to make new medical discoveries and create more effective, targeted medicines for everybody.

Job Description

Our Regulatory Affairs Manager is an important role for us, responsible for establishing regulatory compliance, to ensure we are operating within guidelines and managing documents efficiently.

In this position you will be both inward looking (working diligently to assure compliance, support all Quality Management System related activities as directed by the Head of QIRA and the regulatory QA approver (pre/post release of products), and also outward looking (monitoring the regulatory landscape, keeping the Head of QIRA updated on Regulatory strategy changes and keeping Genomics England well governed in the face of change).

This is an opportunity for a skilled Regulatory Affairs professional to join us in our mission to advance personalised genomic medicine within the UK - making a difference to the lives of patients.

Skills and Experience for Success

We anticipate the ideal candidate will have:

  • Expert knowledge of the medical device regulations such as IVDD, IVDR and MDR
  • Demonstrable understanding of harmonised ISO standards
  • Proven experience with working with Software as a Medical Device (SAMD)
  • Proven ability in drafting and updating technical documentation and to prepare comprehensive and actionable reports on time
  • Familiarity with clinical research and the NHS (National Health Service).
  • Good understanding of the elements of a Quality Management System
  • Proven expertise in planning and conducting audits and writing audit reports
  • Good understanding of the nonconformity/CAPA process
  • Up to date knowledge of the relevant ISO standards and regulatory requirements

Qualifications

Bachelor’s degree in a technical or related field
Auditor qualification or experience in auditing
Regulatory experience in the industry

Additional Information

Originally conceived as a project, Genomics England has transformed to meet the long-term opportunities created by our scientific breakthroughs in understanding the Human Genome. Being part of this journey is a reward in itself, however we're pleased to offer our colleagues a great benefits package including:

  • competitive salary
  • 30 days holiday
  • generous pension scheme
  • individual learning budgets for every colleague
  • a raft of other benefits

Talk to our Talent Team and find out how a career with Genomics England will benefit you.
#LI-Hybrid

As part of our recruitment process, all successful candidates are subject to a Standard Disclosure and Barring Service (DBS) check. We therefore require applicants to disclose any previous offences at point of application, as some unspent convictions may mean we are unable to proceed with your application due to the nature of our work in healthcare.

Genomics England operate a blended working model, as we know our people appreciate the flexibility. We expect most people to come into the office 2 times each month as a minimum. However, this will vary according to role and will be agreed with your team leader. For some people this is 1 day a quarter, for others it is several days a week. There is no expectation that staff will return to the office full time unless they want to. The exception would be some of our roles that would require you to be on site full time e.g., lab teams, reception team.

Our teams and squads have, and will continue to, reflect on what works best for them to work together successfully and have the freedom to design working patterns to suit, beyond the minimum. Our office locations at the moment are Cambridge and Farringdon (London) and in Autumn 2022 we are relocating our London office location to Canary Wharf. We will also be expanding our regional offices.

Looking ahead to our move to Canary Wharf, we will be designing our new space with blended working in mind, and with the flexibility to adapt to changing work patterns. During the pandemic we will be following government advice on working from home guidance.

#hybrid

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Screening Questions

Do you hold the current right to work in the UK?
Will you now or in the future need a visa or work permit in order to work in the UK?

Diversity and Inclusion is important to Genomics England. We want an organisation where you can bring your whole self and feel welcome and included in our mission and workplace. We use the answers to these questions completely anonymously to track and report on our progress in attracting and hiring a diverse workforce. Your answers to these questions are not visible to recruiters or hiring managers and are not used in the selection process.

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