Senior Manager, Product Safety Risk Management – Medical Device

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🕒 Maio 21

🎸 Mississippi – Remoto

🎸 Mississippi – Remote

💵 $145.806 - $218.710 / ano

⏰ Tempo Integral

🟠 Sênior

🎲 Riscos

🦅 Patrocina Visto H1B

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Merative

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2022

⚕️ Seguro de Saúde

☁️ SaaS

🤖 Inteligência Artificial

Healthcare Insurance • SaaS • Artificial Intelligence

A Merative é uma empresa de dados, tecnologia e análises voltada para a saúde. Oferece uma gama de soluções com o objetivo de melhorar os resultados de saúde ao focar no suporte à decisão clínica, análises de saúde, imagem médica, desenvolvimento clínico e serviços de saúde e assistência social. Os principais produtos e serviços incluem o Micromedex para suporte à decisão clínica, o Zelta para gestão de dados clínicos, o Merge para soluções de imagem, e o Truven para análises de saúde. A Merative atende uma clientela diversificada, incluindo provedores de saúde, empresas de ciências da vida, governos, planos de saúde e empregadores. A empresa é dedicada a aprimorar a entrega de cuidados de saúde e a tomada de decisões, aproveitando dados do mundo real e análises avançadas para fornecer insights acionáveis e soluções personalizadas.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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!