Clinical Regulatory Affairs Specialist

Job Reference: WM – 1947

Location: Cambridge

Salary: £45,000 - £50,000

Job Type: Permanent

Job Description

Clinical Regulatory Affairs Specialist

Responsibilities:

  • Reporting to the Risk and Regulatory Manager to ensure all the post market regulatory clinical activities are performed and up to date
  • Advising and steering the clinical team in clinical trials, clinical investigation and clinical development plan
  • You’ll have oversight of clinical development (pre-and post-market activities) as well as overall responsibility for clinical operations and documentation in the run-up to the conformity assessment and application submission for market authorisation
  • Coordinating conceptualisation of confirmatory clinical investigation, authoring clinical investigation plans, coordinating reviews, writing SOPs, and all submission package documents.
  • Updating Post market Surveillance PMS plan, PSUR and PMS report as required
  • Develop Clinical risk hazard analyses, risk management controls and systems
  • Design processes to eliminate or mitigate potential risks and create contingency plans to manage crises. Evaluate existing policies and procedures to find weaknesses
  • Revising literature review processes (ongoing and periodic) as required
  • Identify, collate, assess, and ensure risk mitigation process is followed across the business throughout the relevant departments

About You:

  • Coordinating conceptualisation of confirmatory clinical investigation, authoring clinical investigation plans, coordinating reviews, writing SOPs, and all submission package documents
  • Updating clinical evaluation reports (periodic literature review, systematic literature review, state of the art) for class 1, and class 2a and 2b medical devices
  • Revising literature review processes (ongoing and periodic) as required
  • Clinical evaluation and scientific writing, such as clinical and pre-clinical protocols and study reports

It would also be helpful if you have:

  • A Bachelor’s degree in Science or Engineering or equivalent on the job experience
  • An industry recognised Risk Management Practitioner / Qualification
  • A strong attention to detail and the ability to multi-task and balance competing priorities
  • The ability to get up to speed quickly and effectively build relationships between Regulatory Affairs and other areas of the organisation
  • A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues and suggest and implement improvements/ efficiencies to existing processes
  • Effective communications skills, with experience of presenting plans in a clear and pragmatic way to colleagues and stakeholders across all levels

Job Application:

If you would like to be considered for this role, please apply to send a copy of your full CV – or call us now.

Whilst this position may not be of interest to you or suit your skills and experience, please don’t hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.

We receive a large number of applications for all of our positions – Therefore, If you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion.

Candidates must be eligible to work and live in the UK