Risk Management Engineer

Job Title: Risk Management Specialist

Location: REMOTE

Duration: Long Term

Risk Management Specialists will support remediation workstreams by ensuring appropriate

consideration of product risk throughout retrospective design reviews and documentation updates. The

team will provide expertise to ensure alignment with applicable risk management expectations under

FDA Quality Management System Regulation (QMSR) and ISO 14971.

Responsibilities

• Provide risk management expertise across remediation workstreams.
• Review design documentation to ensure appropriate consideration of product risk.
• Support retrospective evaluation of risk within design documentation.
• Assist in development of risk-based justifications where documentation gaps exist.
• Ensure risk considerations are incorporated during documentation updates and remediation activities.
• Provide guidance on alignment with risk management expectations under QMSR and ISO 14971.
• Collaborate with cross-functional teams to ensure risk perspectives are appropriately integrated.
  
  

Qualifications

• Experience in risk management within medical device development.
• Experience supporting remediation initiatives within regulated environments.
• Familiarity with risk management principles and methodologies.
• Experience applying or reviewing risk processes aligned with ISO 14971.
• Familiarity with risk management expectations under FDA QMSR and global regulatory frameworks.
• Experience reviewing design documentation with risk considerations.