US & Canada
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.
If you are interested in this position, please use the "Apply Here" form. You may email recruiting@medcase.health with any questions you might have. Our team will be in contact with you with more information soon.