Product Risk Management Owner
Product Risk Management Owner
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Salary Not Disclosed
1 Vacancy
Job Description
The Risk Management Owner is responsible for leading and maintaining the fist management process for medical devices throughout their Lifecycle. This role ensures compliance with ISO 14971 FDA QSR EUNDR and other applicable standards. The Risk Management Owner collaborates cross-functions to identity assess document and communicate product risks ensuring patient safety and regulatory compliance.
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.
- 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 produces or product families.
- Determine and evaluate the emergence of new hazards/hazardous situations.
- 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.
- 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.
- 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 mitigation.
Employment Type
Full-time
