Risk Management Specialist
7 months ago
Exciting Opportunity in Healthcare Technology
**Position**: Risk Management Specialist - Medical Devices
Are you ready to contribute to the future of healthcare technology? Epredia is seeking a talented and dedicated Risk Management Specialist to join our team. As a key player in our organization, you will be at the forefront of ensuring compliance with medical standards and driving excellence in risk management practices.
**Responsibilities**:
**Comprehensive Risk Management**:
Lead risk management activities, incorporating applicable medical standards to ensure product safety and efficacy.
Perform and support risk analysis following ISO14971:2019 guidelines, including Hazard Analysis, FMEAs, and FTAs.
**Design Control Compliance**:
Identify and manage Essential Design Outputs, Critical to Quality (CTQs), and Product Critical Components.
Influence development decisions by assessing risks within new design proposals.
**Documentation and Regulatory Compliance**:
Follow design control processes diligently while generating and reviewing risk management deliverables.
Ensure effective implementation of risk control measures, suitable for regulatory submissions.
Conduct Risk/Benefit analysis for existing and newly identified residual risks.
**Post Market Surveillance**:
Conduct required Risk Management File (RMF) reviews and stay abreast of the industry's state-of-the-art status for Post Market Surveillance activities.
Collaborate with Sourcing and Supplier Quality teams to ensure delivered products align with the risk strategy.
**Continuous Improvement**:
Contribute to investigations of non-conformities (NCRs) and corrective and preventive actions (CAPAs) related to products and processes.
**Certification Audits**:
Act as the Subject Matter Expert (SME) for Risk Management during certification audits, particularly in ISO13485.
**Qualifications**:
A degree in life science or engineering discipline.
Experience in Risk Management to ISO14971:2019 in the IVD/MD Medical Devices industry.
In-depth knowledge of 21 CFR 820, 21 CFR 11, and ISO 13485:2016 associated with the medical device industry.
Understanding and experience with Design Controls.
Strong interpersonal skills, ability to collaborate in multi-disciplinary teams, influence decision-making, and build group consensus.
Excellent written and oral communication skills.
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