Serve as the lead technical device expert during clinical studies, managing and performing on-site and remote technical support for Philips IGT devices - during clinical trials
Act as a clinical and technical SME supporting study teams during study planning, start-up, site identification/qualification, enrollment, follow-up and close out activities
Ensure adherence to study protocols, regulatory requirements (GCP, ISO, FDA), and Philips processes/procedures
Train investigators, coordinators, healthcare professionals, and internal teams on device operation, study protocols, and troubleshooting
Establish, maintain, and cultivate credible relationships with key medical thought leaders, HCPs, and scientific professionals
Troubleshoot and resolve issues promptly, identify areas for process enhancement as well as opportunities for innovation
Requirements
8+ years of relevant experience overall OR 5+ years of experience with Bachelor’s OR 3+ years of experience with Master’s in areas such as Medical Education or equivalent
Experience in Peripheral and Cardiovascular devices (imaging and interventional) is preferred
CATH Lab experience is also preferred
proficient knowledge of local and global regulations, ISO 14155, ICH/GCP guidelines, good documentation practice, and other applicable regulations and standards
bachelor’s/master’s degree in science, Medicine, Engineering or related field preferred OR equivalent combination of education and experience in similar roles within industry
excellent communicator with an ability to work well cross functionally
ability to understand technical device functionalities and educate internally and externally on proper functionality and usage
able to travel up to 50% as required by business needs.
Benefits
generous PTO
401k (up to 7% match)
HSA (with company contribution)
stock purchase plan
education reimbursement
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