Ongoing Opportunity for a Medical Regulatory Manager

Our leading client is looking for a highly skilled Risk Management Specialist with extensive experience in software as a medical device (SaMD) to join their team. As a Risk Management Specialist, you will play a critical role in ensuring the safety and efficacy of our healthcare technology solutions.

Responsibilities:

• Lead risk management activities for software as a medical device, including hazard analysis, risk assessments, and risk mitigation strategies.
• Coordinate the completion of PHAs, dFMEAs, uFMEAs, and other risk assessment activities in compliance with relevant standards and regulations.
• Develop and maintain risk management documentation, including risk management plans, reports, and files.
• Collaborate with cross-functional teams to identify and mitigate risks throughout the product lifecycle.
• Ensure compliance with ISO quality systems (ISO 13485) and US FDA Quality System Regulation (21 CFR 820).
• Stay current with industry standards, regulations, and best practices related to risk management in healthcare technology.

Essential Skills:

• Proven experience in risk management of software as a medical device.
• Coordinated completion of several PHAs, dFMEAs, uFMEAs, or other risk assessment activities.
• Exceptional knowledge of risk management processes, particularly ISO 14971.
• Working knowledge of ISO quality systems (ISO 13485) and US FDA Quality System Regulation (21 CFR 820).
• Experience in risk management of Health IT Systems (DCB0129).
• Familiarity with risk management of artificial intelligence (AI) technologies.
• Previous experience working in healthcare settings.

‍

‍

‍