Sr Manager, Product Safety Risk Management - Medical Device

Sr Manager, Product Safety Risk Management- Medical Device

This is a senior enterprise leadership role responsible for shaping and governing product safety risk management across a complex medical imaging software portfolio. The position ensures that risk management practices are consistently applied across the full product lifecycle, from concept through post-market surveillance. You will define and own the global risk management framework, ensuring alignment with regulatory and quality expectations. Acting as a key decision-maker, you will guide high-impact safety evaluations and support critical product decisions in a highly regulated environment. The role also involves close collaboration with cross-functional teams including engineering, quality, regulatory, and clinical stakeholders. You will serve as a key authority in audits, inspections, and regulatory interactions while driving a strong culture of patient safety and continuous improvement. This position combines strategic leadership, technical depth, and people management within a fast-paced, mission-driven healthcare technology environment.

Accountabilities:

• Own and evolve the enterprise product safety risk management framework, ensuring consistent application across all programs and lifecycle stages.
• Define and maintain policies, procedures, tools, and governance structures aligned with risk-based quality system requirements.
• Lead safety risk strategy for complex medical imaging software programs, ensuring timely escalation, evaluation, and resolution of high-risk issues.
• Integrate risk management practices with design controls, software development lifecycles, usability engineering, cybersecurity risk management, and post-market surveillance.
• Oversee preparation, quality, and completeness of risk documentation, including hazard analyses, FMEAs, fault tree analyses, benefit-risk assessments, and Health Hazard Evaluations.
• Lead post-market safety activities including signal detection, CAPAs, and cross-functional response planning for emerging risks.
• Support regulatory submissions and product lifecycle documentation with robust safety risk inputs.
• Represent the organization in audits, inspections, and regulatory authority interactions, ensuring inspection readiness.
• Build, coach, and develop a high-performing risk management team while establishing performance metrics and continuous improvement practices.

Requirements:

• 8–10+ years of experience in medical devices or healthcare technology, with strong focus on product safety risk management in regulated environments.
• Deep expertise applying risk management principles aligned with ISO 14971 across software-based medical devices and full product lifecycles.
• Strong understanding of quality and regulatory frameworks including ISO 13485, IEC 62304, IEC 62366-1, and 21 CFR Part 820, EU MDR 2017/745, and Canadian medical device regulations.
• Proven ability to lead cross-functional decision-making and clearly communicate complex risk topics to senior stakeholders.
• Experience managing or developing teams within quality, regulatory, or product safety risk functions.
• Background working with Software as a Medical Device (SaMD), agile development, and cloud-based environments.
• Familiarity with tools such as Jira, Aha!, Xray Test Management, and Microsoft 365 is an advantage.
• Bachelor's degree in engineering, computer science, life sciences, or related field (advanced certifications in risk management or regulatory affairs preferred).

Benefits:

• Competitive salary range aligned with market benchmarks ($145,806.80 – $218,710.20 USD).
• Remote-first work culture with flexible hybrid/remote arrangements depending on location.
• Comprehensive health coverage including medical, dental, and vision insurance.
• Flexible vacation policy and paid leave to support work-life balance.
• 401(k) retirement savings plan.
• Infertility and family-forming benefits.
• Tuition reimbursement and employee assistance programs.
• Life insurance and additional wellness-oriented benefits.
• Inclusive equal opportunity workplace with reasonable accommodations available.