Risk Management Manager
Job ID: JOB-13229
Risk Management Manager (Remote)
The Role Risk management is part of the product life cycle, the risk management lead is involved in new product development and product sustaining projects for the International Infusion portfolio. The role is based out of the client site in limerick but can be worked remotely.
- Maintain risk management processes up to date with ISO14971, client requirements, and other relevant standards
- Define way-of-work for Risk Management Files maintenance, including, but not limited to:
- Risk Management Plan
- Hazard Analysis / Risk Assessment (System, D/P/U FMEAs, etc.)
- Benefit-Risk Analysis
- Risk Management Report
- Guide design and project teams on actions related to Risk Management Files and ensure actions are properly executed
- Interact with other functions to define the methodology for Risk related post-production quality activities
- Serve as Subject Matter Expert on Risk Management for International Infusion
Skills & Experience
- Must be able to handle multiple projects and tasks, utilizing a high level of written and oral communication skills.
- Will have a minimum of 5 years of experience in Risk management in Medical Devices (Risk Management Lead – a significant advantage)
- Will have a relevant degree (engineering degree – preferred)
- Will have knowledge and experience in working with ISO13485, ISO14971, EU 2017/745 (MDR)
- Must have Strong organizational skills
- Will have experience with IEC 62304 and IEC 62366 – a significant advantage
For further information on this Risk Management Manager role in Limerick please contact Caroline Kingston on +353 868395531 or email email@example.com Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
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