Senior Risk & Regulatory Specialist

Job Reference: WM – 1950

Location: Cambridge

Salary: £50,000 - £55,000

Job Type: Permanent

Job Description

Senior Risk & Regulatory Specialist

Responsibilities:

  • Reporting to the Risk and Regulatory Manager, you will be responsible for ensuring all the risk management file is up to date and in compliance with ISO 14971 and international medical device requirements
  • Identify, collate, assess, and ensure the risk mitigation process is followed across the business throughout the relevant departments
  • Raise risk awareness across the wider team and develop/provide training where necessary
  • Conduct assessments to define and analyse the relevant possible risks and consequences as well as ensuring audit procedures and processes are fit for purpose
  • Design processes to eliminate or mitigate potential risks
  • Create contingency plans to manage crises and evaluate existing policies and procedures to find weaknesses
  • Prepare reports and present recommendations to help develop risk management controls and systems
  • Deputising for the Risk & Regulatory Manager and helping coach/ mentor others within the team through sharing knowledge, experience, and best practice

About You:

  • 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:
  • ISO13485
  • 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

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