Sr Specialist, Post Market Vigilance
Core
Ensures regulatory compliance and maintains safety standards for Cardinal Health's medical device portfolio by processing complaints and reporting adverse events.
Role type
Senior Specialist, Post Market Vigilance
Builds
Regulatory compliant complaint handling and safety reporting processes for medical devices
Domain
Medical Devices / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
Medical device complaint processing, regulatory assessment, decision tree analysis, complaint coding, stakeholder coordination, investigation support, data reporting
Preferred skills
Post market surveillance experience, complaint handling, medical device quality discipline
Technologies
SmartSolve, Agile PLM, Adobe EchoSign
Responsibilities
Review and process medical device complaints, manage translations, coordinate follow-ups with stakeholders, perform regulatory assessments, approve complaint investigations, conduct no-sample complaint investigations, support CAPA reviews
Seniority
Senior, hands-on IC
