Sr Manager, Product Safety Risk Management- Medical Device

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr Manager, Product Safety Risk Management- Medical Device in United States.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best! Why Apply Through Jobgether? Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time. #LI-CL1