Sr Specialist, Product Safety Risk Management (Medical Device)

TL;DR

Sr Specialist, Product Safety Risk Management (Medical Device): Ensuring the safety and reliability of medical imaging software across its full lifecycle with an accent on ISO 14971-aligned risk management practices. Focus on identifying, assessing, and mitigating safety risks in collaboration with cross-functional engineering, clinical, and regulatory teams.

Location: Must be based in the United States

Salary: $121,128 – $181,692 USD

Company

hirify.global is a recruitment platform connecting candidates with global opportunities through an AI-powered matching process.

What you will do

• 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.
• Develop and review risk management documentation such as FMEAs, hazard analyses, and benefit-risk assessments.
• Integrate safety risk management into design controls, software development processes, and system architecture decisions.
• Support post-market surveillance activities including complaint handling, Health Hazard Evaluations (HHEs), and CAPA execution.
• Support audits, inspections, and regulatory submissions as a subject matter expert.

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.
• Bachelor’s degree in engineering, computer science, life sciences, or related field.

Nice to have

• Advanced certification in risk management.

Culture & Benefits

• Remote-first work culture.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement savings plan and financial wellness support.
• Flexible paid time off.
• Tuition reimbursement and life insurance.
• Infertility and family-forming benefits.