Job Details

The Project Manager, RegulatoryAffairs is responsible for obtaining regulatory approvals and ensurescompliance with FDA and international regulatory agency requirements includingISO, local, state and/or federal requirements. Job Duties:

• Serves as a member on project teams.
• Identifies regulatory requirements in each country.
• Develops worldwide regulatory strategies.
• Prepares, reviews and files worldwide regulatorysubmissions and dossiers to ensure class III medical devices arecommercially available in the U.S. and international markets based on theorganization’s objectives.
• Communicates with regulatory agencies on administrativeand routine matters.
• Document, consolidate, and maintain oral and writtencommunication with regulatory agencies.
• Develops and maintains regulatory files and records.
• Reviews change order documents and ascertain the impacton current regulatory approvals.
• Reviews promotional material and labeling forregulatory compliance.

Required Qualifications

·equivalent related experience

·Proficient computer skills (e.g., MS Office)