Senior Risk Management Specialist

Our client is a start-up medical technology company based in Ireland with operations in continental Europe. They develop cutting edge imaging technology with best-in-class engineering and design capabilities.

They are looking for a Senior Risk Management Specialist to join a highly skilled team working on medical device technology used in clinical and surgical 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
• The Risk Management Specilaist will develop and update Design History File records to support Quality and Regulatory documentation
• Follow design control processes while generating and reviewing Risk Management deliverables e.g. hazards, risk analysis, traceability, risk controls, risk policy, harms list etc.
• Support planning and execution of verification and validation activities
• Initiatives to improve the Risk Management activities and design control procedures
• The Risk Management Specialist will have familiarity with new product introduction/ development (NPI)/ NPD)
• Understand the quality policy and quality system requirements applicable to tasks
• Understanding and application of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019
• Design, Use and Manufacture risk-related analysis methodologies, including but not limited to FMEAs, FTAs and Medical Hazard Analysis

Qualifications

• Either degree level education or practical experience in a comparative position
• Life Sciences Industry

On offer

• Exposure to cutting edge medical technology
• Award-winning company which is growing fast
• Flexible working environment e.g. hybrid working
• Good salary + benefits package + medical + company share scheme

To find out more about Real please visit (url removed)

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy Registered office 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom Partnership Number OC(phone number removed) England and Wales