Senior Manager, Product Safety Risk Management (MedTech)

TL;DR

Senior Manager, Product Safety Risk Management (MedTech): Shaping and governing product safety risk management across a complex medical imaging software portfolio with an accent on regulatory compliance and lifecycle risk assessment. Focus on defining global risk frameworks, leading cross-functional safety evaluations, and ensuring inspection readiness in a highly regulated environment.

Location: Must be based in the United States

Salary: $145,806 – $218,710 USD

Company

hirify.global is an AI-powered recruitment platform connecting top-tier talent with leading companies through objective and fair matching processes.

What you will do

• Evolve the enterprise product safety risk management framework across all product lifecycle stages.
• Lead safety risk strategy for complex medical imaging software, ensuring timely resolution of high-risk issues.
• Integrate risk management with design controls, software development lifecycles, and cybersecurity.
• Oversee preparation of risk documentation including hazard analyses, FMEAs, and Health Hazard Evaluations.
• Represent the organization during audits, inspections, and regulatory authority interactions.
• Coach and develop a high-performing risk management team while establishing performance metrics.

Requirements

• 8–10+ years of experience in medical devices or healthcare technology.
• Deep expertise in ISO 14971 risk management principles for software-based medical devices.
• Strong knowledge of ISO 13485, IEC 62304, IEC 62366-1, 21 CFR Part 820, and EU MDR.
• Proven ability to lead cross-functional decision-making and communicate with senior stakeholders.
• Experience managing teams within quality, regulatory, or product safety functions.
• Background in Software as a Medical Device (SaMD) and cloud-based environments.

Culture & Benefits

• Competitive salary range with 401(k) retirement savings plan.
• Remote-first work culture with flexible arrangements.
• Comprehensive health coverage including medical, dental, and vision insurance.
• Flexible vacation policy and paid leave.
• Infertility and family-forming benefits.
• Tuition reimbursement and employee assistance programs.