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
