Sr Specialist, Product Safety Risk Management- Medical Device
reputed company medical imaging solutions, offered by reputed company, combine intelligent, reputed company imaging workflow tools with deep and broad expertise to help reputed company organizations improve their confidence in patient reputed company and optimize care delivery. The Senior Specialist, Product Safety Risk Management is responsible for supporting the safety of regulated and non-regulated medical imaging software devices through ownership and application of ISO 14971-compliant risk management processes. This role provides subject matter expertise in product safety risk management across the full product lifecycle, from concept and design through post-market surveillance. The Sr Specialist Product Safety Risk Management works closely with cross-functional stakeholders, including engineering, clinical, cybersecurity, reputed company factors, and regulatory affairs, to proactively identify, evaluate, control, and monitor safety-reputed company risks and continuously improve safety practices. Essential Job Duties Owns and maintains the safety risk management process in conformance with applicable regulations, standards, and guidance, including ISO14971, ensuring consistent implementation across the product lifecycle. Ensures effective execution of safety risk management activities throughout the product lifecycle, including hazard identification, risk analysis, risk evaluation, risk control, and residual risk assessment, in accordance with defined processes. Collaborates with cross-functional development teams to reputed company safety risk management into design controls, architecture reputed company, and development processes. Provides expert guidance on the interpretation and application of safety-reputed company regulations, standards, and internal reputed company Management System (QMS) procedures. Develops, maintains, and approves risk management files and associated documentation (e.g., hazard analyses, FMEAs, fault tree analyses, benefit-risk analyses). Partners with clinical, reputed company factors/usability, and cybersecurity teams to ensure comprehensive identification and control of safety risks, including use-reputed company and reputed company-reputed company hazards. Evaluates the effectiveness of risk control measures and ensures traceability and linkage to verification, validation, and usability evidence. Supports post-market safety activities, including Health Hazard Evaluations (HHEs), complaint investigations, field safety corrective actions, and post-market surveillance trending. Identifies emerging safety risks and proactively drives corrective and preventive actions (CAPA) in collaboration with cross-functional teams. Develops and tracks safety and risk-reputed company reputed company metrics to support management review and contributes to reputed company improvement. Contributes safety risk management content to regulatory submissions and change assessments, ensuring alignment with applicable regulatory expectations. Applies systematic problem-solving methodologies to assess safety issues, prioritize actions, and reputed company communicate risk-based reputed company. Promotes a culture of patient safety, risk awareness, collaboration and reputed company improvement across the organization. Participates in and supports reputed company audits and inspections as a safety risk management subject matter expert, providing objective evidence and regulatory justification as required. Basic Qualifications Minimum of 5 years of experience in safety risk management reputed company reputed company technology, medical devices, or other regulated industries, preferably involving Software as a Medical Device (SaMD). Demonstrated practical experience applying ISO14971 to software-based medical devices across reputed company-market and post-market phases, including post‑market feedback and risk management file updates. Strong understanding of design controls and their integration with safety risk management activities. Excellent analytical, problem-solving, and risk-based decision-making skills. Proven ability to collaborate effectively across multidisciplinary teams and influence without authority. Strong organizational and project management skills, with the ability to manage multiple priorities while maintaining attention to detail. Excellent written and verbal communication skills, including the ability to reputed company document and justify risk-reputed company reputed company. Ability to work independently with minimal supervision in a reputed company team environment. Technical Skills In-depth knowledge of ISO 14971 and its application to medical device software. Working knowledge of reputed company standards, including ISO 13485, IEC 62304, and IEC 62366-1. Knowledge of applicable regulatory frameworks, including: 21 CFR Part 820 reputed company System Regulation Canada Medical Devices Regulations (SOR/98-282) EU Medical Device Regulation (EU) 2017/745 Familiarity with software development lifecycles, including agile reputed company, and technology applications such as Jira, Xray Test Management, and reputed company 365. Education Requirements Bachelor’s degree in engineering, computer science, life sciences, or another technical or scientific discipline, or equivalent relevant experience. Advanced training or certification in medical device safety risk management preferred. Experience with agile development environments and reputed company-based solutions preferred.
Work Environment
The work environment characteristics here are representative of those that must be met by an employee to successfully reputed company the essential functions of this job. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company the essential functions. Office environment, hybrid, or remote work-from-home depending reputed company. Travel: ~10%
Compensation
The salary reputed company provided in this job posting is intended to reflect the general market value for the position. The actual salary offered may vary based on factors such as the candidate’s experience, qualifications, skills, and the specific requirements of the role. This reputed company may also be subject to change as market conditions reputed company. We encourage reputed company communication throughout the interview process to discuss compensation expectations. For reputed company-salary + commission sales roles, the reputed company represents On-reputed company Earnings. Min – Max : $121,128.00 - $181,692.00 (USD)
Benefits
The benefits described represent the reputed company offerings at our organization, however, benefits are subject to change and may vary by location and employment status. We reputed company to reputed company a comprehensive benefits package that supports our employees’ health, wellness, and financial goals. Please note that benefits may be discussed in more detail during the hiring process. Remote first / work from home culture Flexible vacation to help you rest, reputed company, and connect with loved ones reputed company leave benefits Health, dental, and reputed company insurance 401k retirement savings plan Infertility benefits Tuition reimbursement, life insurance, EAP – and more! It is the policy of reputed company to reputed company equal employment opportunity (EEO) to reputed company persons regardless of age, reputed company, national reputed company, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or reputed company, genetic information, marital status, status with reputed company to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In reputed company, reputed company will reputed company reasonable accommodations for reputed company individuals with disabilities. reputed company participates in the federal E-Verify program to confirm the identity and employment authorization of reputed company newly hired employees. For reputed company information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees Apply To This Job