Senior Manager, Product Safety Risk Management – Medical Device

Merative

Senior Manager leading product safety risk management across the medical imaging software portfolio. Ensuring compliance with ISO 14971 and effective monitoring of product risk performance.

Posted 5/22/2026full-timeRemote • Mississippi • 🇺🇸 United StatesSenior💰 $145,807 - $218,710 per yearWebsite

Tech Stack

Tools & technologies

CloudCyber Security

About the role

Key responsibilities & impact

Owns the product safety risk management framework and governance model
Defines, implements, and continuously improves policies, procedures, templates, tools, and quality system controls
Leads safety risk strategy for medical imaging portfolio and complex programs
Ensures product safety risk management is fully integrated with design controls
Oversees the quality and completeness of risk management files and related documentation
Leads post-market safety activities
Contributes product safety risk management content for regulatory submissions
Serves as the primary product safety risk management leader for audits, inspections, and regulatory interactions
Builds organizational capability by leading and developing talent
Promotes a culture of patient safety, accountability, and continuous improvement

Requirements

What you’ll need

8–10 years of progressive experience in medical device or healthcare technology
Demonstrated expertise applying ISO 14971 to software-based medical devices across pre-market and post-market phases
Strong understanding of design controls and their integration with usability engineering, cybersecurity risk management, software development lifecycles, and post-market surveillance
Proven ability to influence senior stakeholders, lead cross-functional decision making, and communicate complex risk issues with clarity and judgment
Demonstrated experience leading, managing, or developing professionals in safety risk management or closely related quality and regulatory functions
Advanced knowledge of related standards and regulations, including ISO 13485, IEC 62304, IEC 62366-1, 21 CFR Part 820, the Canada Medical Devices Regulations, and EU MDR 2017/745
Experience supporting Software as a Medical Device and modern software development environments, including agile methodologies and cloud-based solutions
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

Benefits

Comp & perks

Remote first / work from home culture
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!

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

ISO 14971design controlsusability engineeringcybersecurity risk managementsoftware development lifecyclepost-market surveillancemedical device risk managementquality systemsregulatory affairsagile methodologies

Soft Skills

influence senior stakeholderslead cross-functional decision makingcommunicate complex risk issueslead and develop talentpromote patient safetyaccountabilitycontinuous improvement

Certifications

advanced training in medical device risk managementadvanced training in quality systemsadvanced training in regulatory affairs