risk management subject matter expert

$125,070 - $174,762/Yr

Randstad

Full-time - Mid Level

Remote

Administrative and Support Services

About the position

The Risk Management Subject Matter Expert will lead risk management activities for a leading medical device company, focusing on compliance with EU MDR and relevant standards. This remote position requires collaboration with cross-functional teams to enhance risk management practices and ensure the safety and efficacy of medical devices.

Responsibilities

• Serve as a Subject Matter Expert in Risk Management within the Design Quality Assurance team.
• Perform gap assessments of usability and risk management documentation against EU MDR requirements, ISO 14971:2019, and IEC 62366-1:2015.
• Provide leadership, guidance, and supervision in risk management throughout remediation projects.
• Collaborate with cross-functional teams, including design and development, regulatory affairs, medical affairs, and manufacturing engineering.
• Develop efficient and robust processes, procedures, tools, and technology to enhance risk management practices.
• Lead the creation and implementation of key performance indicators (KPIs) and metrics for the risk management process.
• Support post-market surveillance activities by creating Health Impact Assessments and Health Hazard Evaluations.
• Apply statistical techniques to calculate probabilities of hazardous situations occurring (p1).
• Utilize expertise in usability engineering and risk management industry best practices, processes, tools, and technology.
• Ensure compliance with all classes of medical devices in alignment with relevant standards and regulations.

Requirements

• Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical).
• 5-7 years of experience in the medical device industry with demonstrated expertise in Risk Management (ISO 14971:2019).

Benefits

• Health insurance
• 401K contribution
• Incentive and recognition program