Senior Risk Management Specialist

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Our lawsuit is simply a start-up aesculapian exertion institution based successful Ireland with operations successful continental Europe. They make cutting borderline imaging exertion with best-in-class engineering and plan capabilities.

They are looking for a Senior Risk Management Specialist to articulation a highly skilled squad moving connected aesculapian instrumentality exertion utilized successful objective and surgical settings.

The Risk Management Specialist volition beryllium liable for developing, maintaining, and supporting the company's hazard absorption record for aesculapian instrumentality development. This is simply a cardinal presumption during a play of maturation for the company.

The presumption offers Hybrid moving for those that request it and the accidental to partake successful the aboriginal occurrence of the business.

Responsibilities:

  • Risk absorption activities, including the incorporation of applicable aesculapian standards
  • Prepare, present, and pb formal/informal reviews of results, deigns, and analyses, and thrust alignment with peers, task team, and cross-functional stakeholders
  • The Risk Management Specilaist volition make and update Design History File records to enactment Quality and Regulatory documentation
  • Follow plan power processes portion generating and reviewing hazard absorption deliverables e.g. hazards, hazard analysis, traceability, usability, hazard controls, hazard policy, harms database etc.
  • Support readying and execution of verification and validation activities
  • Initiatives to amended the hazard absorption activities and plan power procedures
  • The Risk Management Specialist volition person familiarity with caller merchandise introduction/ improvement (NPI)/ NPD)
  • Understand the prime argumentation and prime strategy requirements applicable to tasks
  • Understanding and exertion of Design Controls per 21 CFR 820.30 and Risk Management per ISO 14971:2019
  • Design, Use and Manufacture risk-related investigation methodologies, including but not constricted to FMEAs, FTAs and Medical Hazard Analysis

Qualifications

  • Either grade level acquisition oregon applicable acquisition successful a comparative position
  • Life Sciences Industry

On offer

  • Exposure to cutting borderline aesculapian technology
  • Award-winning institution which is increasing fast
  • Flexible moving situation e.g. hybrid working
  • Good wage + benefits bundle + aesculapian + institution stock scheme

To find retired much astir Real delight sojourn www.realstaffing.com

Real Staffing, a trading part of SThree Partnership LLP is acting arsenic an Employment Agency successful narration to this vacancy| Registered bureau | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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