Senior Regulatory Affairs Specialist

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Tue, Jun 06, 2023

Job Summary

A company in the healthcare industry is looking for a Senior Regulatory Affairs Specialist.

Position Responsibilities:
  • Prepare regulatory submissions for FDA and foreign countries
  • Develop regulatory strategies and review design transfer activities
  • Collaborate with cross-functional teams to ensure regulatory compliance and support product development
Required Qualifications:
  • Bachelor's degree in science or related field
  • 5 years of regulatory experience in medical devices
  • Proven ability to prepare and submit documents to FDA
  • Excellent understanding of FDA requirements, ISO Standards, and other international requirements
  • Experience working with cross-functional teams on product development and manufacturing projects

COMPLETE JOB DESCRIPTION

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