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Requirement Details

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Project Manager, Regulatory Affairs Location: Aliso Viejo, California
Desription

PositionOverview

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 regulatory submissions and dossiers to ensure class III medical devices are commercially available in the U.S. and international markets based on the organization’s objectives.
  • Communicates with regulatory agencies on administrative and routine matters.
  • Document, consolidate, and maintain oral and written communication with regulatory agencies.
  • Develops and maintains regulatory files and records.
  • Reviews change order documents and ascertain the impact on current regulatory approvals.
  • Reviews promotional material and labeling for regulatory compliance.

Required Qualifications

·equivalent related experience)

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