Merative

Merative

Sr Manager, Product Safety Risk Management- Medical Device

Remote – United States, USA · Senior

Sponsorship not specified$146k-$219kDetected 31 days ago
RESTCybersecurityAgileJiraFDA RegulatoryMedical DevicesRadiologyLeadershipCommunicationCollaborationMentoringRegulatory Affairs

About the role

  • Success in this role is reflected in sustained inspection readiness, timely and high-quality risk decisions, and effective detection and response to emerging post-market safety signals.
  • This range may also be subject to change as market conditions evolve.
  • For base-salary + commission sales roles, the range represents On-Target Earnings.

Responsibilities

  • Owns the product safety risk management framework and governance model, ensuring consistent application of ISO 14971-aligned practices across the portfolio and throughout the product lifecycle.
  • Defines, implements, and continuously improves policies, procedures, templates, tools, and quality system controls that enable effective and scalable product safety risk management.
  • Contributes product safety risk management content for regulatory submissions, design changes, and product lifecycle assessments.
  • Builds organizational capability by leading and developing talent, and establishing performance metrics to monitor the effectiveness of product safety risk management processes and product performance.

Requirements

  • Strong understanding of design controls and their integration with usability engineering, cybersecurity risk management, software development lifecycles, and post-market surveillance.
  • The work environment characteristics here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Skills

  • Relevant advanced training or certification in medical device risk management, quality systems, or regulatory affairs.
  • Experience with enabling technologies and work management platforms such as Jira, Aha!, Xray Test Management, and Microsoft 365 preferred.
  • Supervisory Skills
  • Exercises sound judgment and operates effectively with a high degree of independence in a complex, matrixed environment.
  • Education Requirements
  • Bachelor's degree in engineering, computer science, life sciences, or another scientific or technical discipline, or equivalent experience.
  • Advance training or certification in medical device risk management, quality systems, or regulatory affairs preferred
  • Experience with agile development and cloud solutions preferred.
  • Work Environment

Compensation

  • The salary range 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 range may also be subject to change as market conditions evolve.
  • We encourage open communication throughout the interview process to discuss compensation expectations.
  • For base-salary + commission sales roles, the range represents On-Target Earnings.
  • $145,806.80 - $218,710.20 (USD)

Benefits

  • Flexible vacation to help you rest, recharge, and connect with loved ones
  • Paid leave benefits
  • Health, dental, and vision insurance
  • 401k retirement savings plan
  • Infertility benefits
  • Tuition reimbursement, life insurance, EAP - and more!
  • We strive to provide 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.
  • Leads safety risk strategy for medical imaging portfolio and complex programs, providing decision support to cross-functional leaders and ensuring timely, risk-based escalation and resolution.
  • Leads post-market safety activities, including safety signal assessment, Health Hazard Evaluations, CAPAs, and cross-functional response planning, to ensure effective monitoring of product risk performance.
  • The benefits described represent the current offerings at our organization, however, benefits are subject to change and may vary by location and employment status.

Visa & Work Authorization

  • icy of Merative to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orient
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This listing is sourced directly from Merative's careers page and normalized into a canonical job model.