Principal, Product Safety Risk Management

Job not on LinkedIn

🔥 10 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $152.8k - $229.2k / year

⏰ Full Time

🔴 Lead

✅ Product Manager

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Merative

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2022

⚕️ Healthcare Insurance

☁️ SaaS

🤖 Artificial Intelligence

Healthcare Insurance • SaaS • Artificial Intelligence

Merative is a healthcare data, technology, and analytics company. It offers a range of solutions aimed at improving health outcomes by focusing on clinical decision support, healthcare analytics, medical imaging, clinical development, and health and human services. Key products and services include Micromedex for clinical decision support, Zelta for clinical data management, Merge for imaging solutions, and Truven for healthcare analytics. Merative serves a diverse client base, including healthcare providers, life sciences companies, governments, health plans, and employers. The company is dedicated to enhancing healthcare delivery and decision-making by leveraging real-world data and advanced analytics to provide actionable insights and tailored solutions.

📋 Description

• Provides expert technical leadership for safety risk management activities • Leads complex risk management analyses and documentation activities • Serves as a principal technical advisor to product development and quality teams • Interprets and applies complex safety-related regulations • Develops, maintains, reviews, and approves risk management files • Integrates clinical, human factors/usability, cybersecurity, interoperability, and post-market evidence into practices • Evaluates risk control effectiveness • Provides senior expert review for post-market safety activities • Identifies systemic or emerging safety risks • Develops and interprets safety and risk-related quality metrics • Leads technical contributions to regulatory submissions • Applies advanced problem-solving methodologies • Mentors and guides less experienced team members • Promotes a culture of patient safety, risk awareness, collaboration, quality ownership, and continuous improvement

🎯 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 • Extensive practical experience applying ISO 14971 to software-based medical devices across pre-market and post-market phases • Deep understanding of design controls and demonstrated ability to integrate safety risk management into product architecture • Advanced analytical, problem-solving, and risk-based decision-making skills • Proven ability to influence cross-functional stakeholders without direct authority • Strong prioritization, technical leadership, and change management skills • Excellent written and verbal communication skills • Technical Skills: Expert-level knowledge of ISO 14971 and its application to medical device software • Advanced working knowledge of related standards and expectations • Strong knowledge of applicable regulatory frameworks • Strong familiarity with software development lifecycles, including agile methods

🏖️ Benefits

• 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!