Sr Specialist, Product Safety Risk Management - Medical Device

Sr Specialist, Product Safety Risk Management- Medical Device

This role is focused on ensuring the safety and reliability of medical imaging software across its full lifecycle, from design through post-market performance. You will serve as a key subject matter expert in product safety risk management, helping to embed ISO 14971-aligned practices into regulated software development environments. The position plays a critical role in identifying, assessing, and mitigating safety risks in collaboration with engineering, clinical, cybersecurity, and regulatory teams. You will contribute directly to improving patient safety outcomes by ensuring robust risk evaluation and control strategies are consistently applied. The environment is highly cross-functional and quality-driven, requiring strong analytical and communication skills. This is a hands-on role with exposure to both pre-market development and post-market surveillance activities in a global healthcare technology context.

Accountabilities:

• 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.

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).

Benefits:

• Competitive compensation aligned with market benchmarks ($121,128 – $181,692 USD).
• Remote-first work culture with flexible arrangements depending on location.
• Comprehensive medical, dental, and vision insurance coverage.
• Flexible paid time off to support rest and work-life balance.
• 401(k) retirement savings plan and financial wellness support.
• Tuition reimbursement, life insurance, and employee assistance programs.
• Infertility and family-forming benefits.
• Inclusive equal opportunity workplace with reasonable accommodations available.