Sr Manager, Product Safety Risk Management- Medical Device
Remote – United States, United States
R
USD 145K-218K Senior-level Full Time
Tasks
- Assess safety signals and emerging post market risks
- Build and develop safety risk management teams
- Conduct health hazard evaluations
- Conduct residual risk evaluation
- Define performance metrics for risk management effectiveness
- Develop cross functional response plans
- Ensure ISO 14971 aligned risk based approach
- Ensure post market surveillance risk management
- Establish governance and decision quality
- Integrate risk management with cybersecurity risk management
- Integrate risk management with design controls
- Integrate risk management with software development lifecycle
- Integrate risk management with usability engineering
- Integrate risk management with verification and validation
- Lead audits inspections and regulatory interactions
- Lead fault tree analysis and benefit risk analysis
- Lead hazard analysis and FMEA activities
- Maintain inspection readiness
- Manage CAPA activities
- Oversee risk management files and documentation
- Own product safety risk management framework
- Support regulatory submissions with risk content
Perks/Benefits
- 401k retirement savings plan
- EAP
- Flexible vacation
- Health, dental, and vision insurance
- Infertility benefits
- Life insurance
- Paid leave benefits
- Remote first work from home culture
- Tuition reimbursement
Skills/Tech-stack
21 CFR | 21 CFR part 820 | 62366-1 | Agile | Aha! | Benefit Risk Analysis | CAPA | CFR Part 820 | Cybersecurity Risk Management | Cybersecurity risk | Design Controls | Development Lifecycle | EU MDR | EU MDR 2017 745 | FMEA | Fault Tree | Fault Tree Analysis | Hazard Analysis | Health Hazard | Health Hazard Evaluations | IEC 62304 | IEC 62366 | IEC 62366-1 | ISO 13485 | ISO 14971 | Jira | MDR 2017 745 | Market surveillance | Medical Device | Medical device regulations | Microsoft 365 | Part 820 | Post-Market Surveillance | Residual Risk | Risk Analysis | Risk Management | Software Development Lifecycle | Software development | Test Management | Tree analysis | Usability Engineering | Verification and Validation | XRay test management | Xray Test
Education
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