Risk Management Specialist

Position: Product Owner - Risk Management

Location: Round lake, IL – Onsite

Role: 12 Months - Contract

Job Summary:

The Risk Management Owner is responsible for leading and maintaining the risk management process for medical devices throughout their lifecycle. This role ensures compliance with ISO 14971, FDA QSR, EU MDR, and other applicable standards. The Risk Management Owner collaborates cross-functionally to identify, assess, document, and communicate product risks, ensuring patient safety and regulatory compliance.

Key Responsibilities:

Risk File & Documentation Management:

• Manage the Risk Management File (RMF) and associated Design History File (DHF) documents.
• Ensure risk-related documentation is complete, accurate, and compliant with regulatory requirements.
• Maintain traceability between risk documents and design controls.

Risk Assessment & Review:

• Conduct regular risk reviews to evaluate product safety and performance.
• Manage and implement RMF changes based on design updates, complaints, or post-market data.
• Select applicable hazards and hazardous situations for specific products or product families.
• Determine and evaluate the emergence of new hazards/hazardous situations.

Cross-Functional Collaboration:

• Select and coordinate a cross-functional risk management team including representatives from R&D, Clinical, Regulatory, and Quality.
• Collaborate with Clinical/Medical Affairs to evaluate and approve new hazards/hazardous situations.
• Ensure technical content is provided by qualified team members.
• Delegate specific risk-related activities to qualified personnel.

System Engineering Support:

• Provide guidance to design teams on implementing effective risk mitigation strategies and conducting thorough requirement reviews.
• Establish and maintain a traceability matrix to ensure clear linkage between product requirements and verification activities.
• Lead the development and review of system-level verification and validation plans, and support issue analysis testing when necessary.
• Mentor team members on engineering best practices to proactively minimize product risks and enhance overall system reliability.

Communication & Risk Strategy:

• Develop mechanisms to document and communicate product risks across the organization.
• Communicate changes in product risk to internal and external stakeholders as appropriate.
• Collaborate with other product safety experts to ensure alignment on risk strategy and execution.