Sr Specialist, Product Safety Risk Management- Medical Device
USD 121K-181K Senior-level Full Time
Tasks
- Apply problem-solving methodologies
- Assess residual risk
- Communicate risk based decisions
- Conduct fault tree analysis
- Conduct health hazard evaluations
- Control security related hazards
- Control use related hazards
- Develop FMEA
- Develop hazard analyses
- Drive CAPA
- Evaluate risk
- Identify emerging safety risks
- Identify hazards
- Implement risk controls
- Integrate safety risk management into design controls
- Interpret regulatory standards
- Investigate Complaints
- Maintain risk management files
- Own safety risk management process
- Perform benefit risk analysis
- Perform post market surveillance trending
- Perform risk analysis
- Support change assessments
- Support external audits
- Support field safety corrective actions
- Support inspections
- Support internal audits
- Support regulatory submissions content
- Track safety quality metrics
- Validate usability evidence
- Verify traceability to evidence
Perks/Benefits
- 401k retirement savings plan
- Employee assistance program
- 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 | Benefit Risk Analysis | CAPA | CFR Part 820 | Complaint investigation | Corrective Action | Design Controls | EU 2017 745 | FMEA | Fault Tree | Fault Tree Analysis | Field Safety Corrective Action | Field safety | Hazard Evaluation | Hazard Identification | Health Hazard | Health Hazard Evaluation | IEC 62304 | IEC 62366 | IEC 62366-1 | ISO 13485 | ISO 14971 | Jira | Management System | Market surveillance | Medical Device | Medical device regulation | Microsoft 365 | Part 820 | Post-Market Surveillance | Quality Management System | Quality management | Residual Risk | Residual risk assessment | Risk Analysis | Risk Assessment | Risk Evaluation | Risk control | Test Management | Traceability | Tree analysis | Usability | Usability Testing | Validation | Verification | XRay test management | Xray Test
Education
Bachelor of Arts | Bachelor of Engineering | Bachelor of Science
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