Risk Management Specialist

2 weeks ago


Runcorn, United Kingdom Epredia Full time

As a Risk Management Specialist, you will gather, analyze, and manage risk management data, and prepare reports to management and outside agencies as required. You will participate in the review, investigation, and evaluation of actual and potential risks and serve as a resource to staff and management by participating in committee meetings and safety initiatives.

**What you will do**: Perform and support Risk Analysis in accordance with ISO14971:2019, i.e., Hazard Analysis execution with Design Validation Specialist and DFMEA/FTA execution with R&D/EPD Engineers

Identify and handle Essential Design Outputs, CTQs, and Product Critical Components

Assess risks within new designs proposals and influences developments

Assess the Design Changes Requests (DCRs) for risk management and executes risk strategies, as the need arises

Ensure the implementation of risk control measures is effective and suitable for regulatory submissions

Perform Risk/Benefit analysis for existing and newly identified residual risks

Conduct required RMF reviews and state-of-the-art status for Post Market Surveillance activities

Work with Sourcing and Supplier Quality teams to ensure the delivered product is compliant with the risk strategy

Take part in complaints reviews and root cause analyses (5Why, Ishikawa, A3, 8D) to determine appropriate risk evaluations and risk controls

Participate in product and related processes NCRs & CAPAs investigations

Continuously improve the process maintaining its effectiveness and compliance

Act as the SME for Risk Management during certification audits (ISO13485(current)

**Skills you will need**: Bachelor’s degree in a related field with 2+ years of experience in a Risk Management role.

Must have excellent interpersonal, verbal, and written communication skills with an ability to make immediate decisions for effective conflict resolution.

Must possess and further develop strong presentation skills.

Ability to handle multiple tasks and prioritize in stressful situations.

Excellent judgment, problem-solving, analytical, and interpretive skills.

Initiative and ability to work with mínimal direction.

Ability to maintain confidentiality.



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