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Job ID: JOB-13229
Risk Management Manager (Remote)

Location: Limerick

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.

Responsibilities

• 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 caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Caroline Kingston

JOB-13229

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