Regulatory Affairs Specialist
- Ensure risk management files are up to date and in compliance with ISO 14971 and international medical device requirements
- Identify, collate, assess, and ensure risk mitigation process is followed across the business throughout the relevant departments
- Conduct assessments to define and analyse the relevant possible risks and consequences as well as ensuring audit procedures and processes are fit for purpose
- Prepare reports and present recommendations to help develop risk management controls and systems
- Design processes to eliminate or mitigate potential risks
- Create contingency plans to manage crises and evaluate existing policies and procedures to find weaknesses
- Experience of ISO14971 Risk Management Systems, IEC62304 Software Development Processes, IEC62366 Human Factors Engineering, ISO14155 Clinical Investigations
- Experience in relevant standards, processes, and systems such as:
The application of risk management ISO 14971
Software development IEC62304
Human factors engineering IEC62366
Electrical medical equipment IEC60601
- Technical knowledge and understanding of a range of disciplines relevant to a high reliability, robust and safety critical, complex electro-mechanical robotic system
- Experience in the creation of technical files, design dossiers and design history for regulatory submissions.
- A Bachelor’s degree in Science or Engineering or equivalent on the job experience, an industry recognised Risk Management Practitioner / Qualification is desirable
- Proven experience in the medical device industry including EU Medical Devices Directive and the new Medical Device Regulation and US 21 CFR 820 FDA regulations
- A methodical approach with strong attention to detail, 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
- Effective communications skills, with experience of presenting plans in a clear and pragmatic way to colleagues and stakeholders across all levels
- 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
- Being computer literate is essential, good written & verbal English also necessary. You will also need to be able to travel occasionally when required.
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