Senior Manager, Product Safety Risk Management – Medical Device

Job not on LinkedIn

🕒 May 21

🎸 Mississippi – Remote

🎸 Mississippi – Remote

💵 $145.8k - $218.7k / year

⏰ Full Time

🟠 Senior

🎲 Risk

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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

• 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

• 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

• 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!