Must Have: 1. Experience supporting, coordinating and / or leading projects 2. Remediation experience (DHF, Regulatory... JOB DESCRIPTION Top 3 technical skills that are required for the role: Remediation experience (DHF, Regulatory compliance, e.g., EU MDR...
. Support Supplier related changes for Commercial products. Maintain high standards for Device History File (DHF) content...
results Support technical execution of Design History File (DHF) updates Establish and maintain relationships...
risk assessments, DHF deliverables, trend signal reviews/reports, and investigations of significant safety risks...
risk assessments, DHF deliverables, trend signal reviews/reports, and investigations of significant safety risks...
projects Participate at the core team level and support tasks such as: DHF document review and management Technical...
and FDA complaint Design history Files (DHF) for each project Manages all aspects of assigned projects to ensure timely...