Sr Manager, Product Safety Risk Management- Medical Device in United States at Jobgether
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Job Description
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.
- 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.
- 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).
- 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.