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2019-03-14 16:58:59
Key Skills:
Project Manager, Regulatory Affairs Location: Aliso Viejo, California
2019-03-14 16:58:59
Job Type:
Full Time only
Budget $: 100,000 - 200,000
Budget $: 100,000 - 200,000
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)
Key Skills:
