Regulatory Specialist Sr

HireTalent
  • Alameda, CA
  • Instant Apply
30+ days ago

Job Description

Job Title: Sr. Regulatory Specialist
Duration: 6+ Months Contract (Possibility of Extension)
Location: Alameda, CA 94502
Shift: 9:00 AM 5:00 PM

Job Description:
  • Must have 7+ years of experience in Medical Device Regulatory Affairs.
  • Highly experienced in regulatory change assessments.
  • Working knowledge of U.S. Medical Device Submissions.
  • Experience with regulatory strategy, risk management, regulatory policy & intelligence, and continuous improvement activities.
  • Ensures timely approval of new medical devices and continued approval of marketed products.
  • Serves as a regulatory representative for cross-functional teams.
  • Advises development/marketing teams on manufacturing changes, line extensions, technical labeling, and applicable regulations/interpretations.

Numbers & Facts

LocationAlameda, CA

Skills

  • Assembly Lineunmatched
  • Continuous Improvementunmatched
  • Cross-Functionalunmatched
  • Interpret Regulationsunmatched
  • Marketingunmatched
  • Medical Equipmentunmatched
  • Product Marketingunmatched
  • Regulationsunmatched
  • Risk Managementunmatched
  • Time Managementunmatched

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