Our client an established medical technology company based in Cheshire are looking for a Risk Management Specialist to join the team. They develop cutting edge medical imaging technology with best-in-class engineering and design capabilities as a market leader within their respective therapy area.
They are looking for a Risk Management Specialist to join a highly skilled team working on medical device technology used in clinical settings. The Risk Management Specialist will be responsible for developing, maintaining, and supporting the company's Risk Management file for medical device development. This is a key position during a period of growth for the company.
The position offers Hybrid working for those that need it and the opportunity to partake in the future success of the business.
Responsibilities:
- Risk management activities, including the incorporation of applicable medical standards
- Prepare, present, and lead formal/informal reviews of results, deigns, and analyses, and drive alignment with peers, project team, and cross-functional stakeholders
- Develop and update Design History File records to support Quality and Regulatory documentation
- Follow design control processes while generating and reviewing Risk Management deliverables
- Support planning and execution of verification and validation activities
- Initiatives to improve the Risk Management activities and design control procedures
- Familiarity with new product introduction/development
- Risk Management per ISO 14971:2019 or Risk Reviews within FMEA
- Design, Use and Manufacture risks
Qualifications
- Either degree level education or practical experience in a comparative position
- Life sciences industry
On offer
- Exposure to cutting edge medical technology
- Flexible working environment eg hybrid working
- Good salary + medical + bonus and benefits package
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales