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The Position
The Opportunity:
As a Diagnostics Regulatory Project Manager you will be responsible to oversee and complete Regulatory documentations associated with regulatory approvals of In Vitro Diagnostics (IVD) medicaid devices and Medical Devices. You are responsible for the activities that lead to and maintain domestic and international regulatory approval for marketed devices. FDA experience is required.
Responsibilities:
• Provides support to currently marketed products, e.g., labeling, product and manufacturing changes and documentation for compliance and for changes requiring regulatory agency approval,
as pertains to regulatory requirements
• Creating, maintenance and approval of regulatory documentation for submissions and for ongoing activities related to compliance with FDA and Integral Regulatory directives and regulations. (e.g stability reports, manufacturer workflows, compositions, etc…)
• Prepare change assessments and general surveys when required, collect answers, create specific reports to the Regulatory Affairs project teams
• Interfaces with internal stakeholders to collect data to prepare, maintain regulatory documentation
• Maintain documentation of the Regulatory Information Management System
• Create and maintain product information on the Regulatory Information Management System
• Create reports on Regulatory Information Management System
• Responsible for maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and re