Principal, Product Safety Risk Management

About the role

The Principal, Product Safety Risk Management is a senior individual contributor and recognized subject matter expert responsible for providing technical leadership and expert execution of product safety risk management activities for regulated and non-regulated medical imaging software devices.

Responsibilities

• Provides expert technical leadership for safety risk management activities in conformance with applicable regulations, standards, and guidance, including ISO 14971, ensuring consistent and effective implementation across assigned products, programs, and lifecycle phases.
• Serves as a principal technical advisor to product development and quality teams, influencing design controls, architecture decisions, product requirements, verification and validation strategy, and release readiness decisions within assigned programs.
• Evaluates risk control effectiveness and ensures robust traceability to requirements, verification, validation, usability, clinical, cybersecurity, and post-market evidence.
• Mentors and guides less experienced team members and cross-functional partners on product safety risk management principles, documentation expectations, and regulatory defensibility.

Requirements

• Minimum of 8 years of progressive experience in safety risk management, quality, regulatory affairs, systems engineering, clinical safety, or related disciplines within healthcare technology, medical devices, or other regulated industries, preferably involving Software as a Medical Device (SaMD).
• Extensive practical experience applying ISO 14971 to software-based medical devices across pre-market and post-market phases, including post-market feedback, risk management file updates, residual risk assessment, benefit-risk evaluation, and regulatory submission support.
• Advanced analytical, problem-solving, and risk-based decision-making skills, including the ability to resolve ambiguous, complex, or high-impact product safety issues.
• Proven ability to influence cross-functional stakeholders without direct authority, drive alignment, and make recommendations that balance patient safety, regulatory expectations, product performance, and business priorities.
• Strong prioritization, technical leadership, and change management skills, with the ability to support multiple complex initiatives while maintaining quality, traceability, and regulatory defensibility.

Qualifications

• Bachelor’s degree in engineering, computer science, life sciences, or another technical or scientific discipline, or equivalent relevant experience.
• Advanced degree in engineering, life sciences, health sciences, regulatory affairs, quality, or a related discipline preferred.
• Advanced training or certification in medical device safety risk management, quality, regulatory affairs, systems engineering, or related discipline preferred.
• Experience with agile development environments, cloud-based solutions, regulated medical device software, and global regulatory expectations preferred.