Sr Specialist, Product Safety Risk Management - Medical Device
New
USFull-TimeSenior
Salary121,128 - 181,692 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- Risk Management
Requirements
- 5+ years of experience in product safety risk management within medical devices, healthcare technology, or regulated software environments.
- Strong expertise applying ISO 14971 across Software as a Medical Device (SaMD) and full product lifecycle activities.
- Working knowledge of related standards such as ISO 13485, IEC 62304, and IEC 62366-1.
- Familiarity with regulatory frameworks including 21 CFR Part 820, EU MDR 2017/745, and Canadian Medical Device Regulations.
- Strong analytical and risk-based decision-making skills with the ability to manage complex safety issues.
- Experience collaborating across multidisciplinary teams and influencing decisions without formal authority.
- Excellent written and verbal communication skills for documenting and justifying risk decisions.
- Bachelor’s degree in engineering, computer science, life sciences, or related field (advanced certification in risk management preferred).
Responsibilities
- Own and maintain ISO 14971-compliant product safety risk management processes across the full software lifecycle.
- Execute risk management activities including hazard identification, risk analysis, evaluation, control, and residual risk assessment.
- Integrate safety risk management into design controls, software development processes, and system architecture decisions.
- Develop, maintain, and review risk management documentation such as FMEAs, hazard analyses, fault tree analyses, and benefit-risk assessments.
- Partner with clinical, human factors, cybersecurity, and engineering teams to ensure comprehensive risk identification and mitigation.
- Evaluate effectiveness of risk controls and ensure full traceability to verification, validation, and usability evidence.
- Support post-market surveillance activities including complaint handling, Health Hazard Evaluations (HHEs), and CAPA execution.
- Identify emerging safety risks and contribute to continuous improvement and corrective/preventive actions.
- Support audits, inspections, and regulatory submissions as a subject matter expert in safety risk management.
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