Senior Specialist, Product Safety Risk Management
United StatesFull-TimeSenior
Salary121,128 - 181,692 USD per year
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Job Details
- Experience
- 5 years
- Required Skills
- Risk Management
Requirements
- Minimum 5 years experience in safety risk management in regulated industries.
- Experience with Software as a Medical Device (SaMD) preferred.
- Practical experience applying ISO 14971 across pre-market and post-market phases.
- Strong understanding of design controls.
- Knowledge of ISO 13485, IEC 62304, and IEC 62366-1.
- Knowledge of 21 CFR Part 820, Canadian SOR/98-282, and EU MDR 2017/745.
- Familiarity with Agile, Jira, Xray, and Microsoft 365.
- Bachelor's degree in engineering, computer science, or life sciences.
- Advanced certification in medical device safety risk management preferred.
Responsibilities
- Owns and maintains the safety risk management process in conformance with ISO 14971.
- Ensures execution of safety risk management activities including hazard identification and risk analysis.
- Collaborates with cross-functional teams to integrate risk management into design controls.
- Develops and approves risk management files and documentation.
- Partners with clinical, human factors, and cybersecurity teams to identify safety risks.
- Supports post-market activities including Health Hazard Evaluations and complaint investigations.
- Identifies emerging safety risks and drives CAPA.
- Contributes to regulatory submissions and change assessments.
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