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Sr Prin Clinical Research Specialist- Post Market Surveillance and Evidence

Medtronic

Mounds View, Minnesota, United States of AmericaSeniorH-1B sponsor company
Sign in to applyVerified 1h ago
Location
Mounds View, Minnesota, United States of America
Work model
On-Site
Level
Senior
H-1B history
106 approvals (FY2023)
Posted
1d ago

About this role

We anticipate the application window for this opening will close on - 18 Aug 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Senior Principal Clinical Research Specialist – Post Market Surveillance and Evidence provides enterprise leadership in the strategic application of real world data (RWD) to support regulatory and post market clinical evidence strategies across Medtronic. This role serves as a recognized subject matter expert and provides strategic consultation to operating units and corporate clinical teams on the appropriate use of RWD to address clinical and regulatory questions and strengthen evidence strategies across the product lifecycle. The role functions in a strategic advisory capacity, helping teams understand how to identify and leverage different RWD sets for regulatory purposes, evaluate potential RWE approaches, assess available data sources, and identify opportunities where real world evidence may complement traditional clinical evidence. The position partners closely with Regulatory Affairs, Health Economics and Outcomes Research (HEOR), the PACS therapy teams, and operating unit clinical research teams to support evidence planning and regulatory engagement strategies while respecting the distinct roles and responsibilities of these functions. This role helps connect existing expertise across clinical, regulatory, and HEOR teams, supporting coordinated evaluation of RWE opportunities and promoting transparency, shared learning, and consistent approaches to the appropriate use of real world data across Medtronic.                     Responsibilities may include the following and other duties may be assigned. Guidance on Real World Evidence for Regulatory and Post Market Clinical Strategy Provide enterprise-level strategic guidance on the use of real-world data and real-world evidence to support regulatory and post market clinical evidence strategies across Medtronic. Provide strategic consultation to operating units and corporate clinical teams on evaluating real world data sources and determining appropriate applications of real-world evidence to address clinical and regulatory questions. Partners with PACS therapy teams, Regulatory Affairs leadership, HEOR leadership, and operating unit clinical teams to evaluate opportunities where real world data and real-world evidence may address regulatory questions or complement traditional clinical trial evidence. Guide operating unit clinical research teams in the strategic integration of real-world data into regulatory and post market clinical evidence plans across the product lifecycle. Identify and advance scalable real-world evidence use cases that support regulatory decision-making and post market clinical evidence generation across multiple operating units. Provide strategic input on clinical real world evidence study concepts, including registry-based studies, observational research, and post market evidence generation strategies. Advise teams on the appropriateness of real-world data approaches versus traditional clinical study designs to ensure regulatory evidence requirements and clinical questions are adequately addressed. Collaborate with Regulatory Affairs and HEOR to evaluate potential real-world evidence approaches while respecting functional ownership of regulatory and health economics strategies.  Strategy Assessment and Advisory Serve as an enterprise subject matter expert providing strategic consultation to operating units and corporate teams on real world data sources, data

Sr Prin Clinical Research Specialist- Post Market Surveillance and Evidence at Medtronic, Mounds View, Minnesota, United States of America | Yoinka