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Regulatory Affairs Specialist

5 months ago

South Plainfield, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Provides administrative support for regulatory affairs manager
  • Provides RA support for change control projects and sustaining activities
  • Conducts regulatory assessments and determines need for re-registration for proposed device changes, prepares internal documentation for changes not requiring re-registration (FDA, EU, OUS)
  • Supports worldwide product registrations through collaboration with regulatory associates and cross-functional product team
  • Responds to requests for product information by customers or other businesses
  • bility to carry out the above tasks with minimal supervision
  • Experience with disposable medical devices
  • Experience with International registrations and renewal.
Requirements
  • Minimum Bachelor's degree; strongly preferred in science or engineering
  • Minimum 1-3 years' experience in Regulatory Affairs in the medical device industry
  • Demonstrated customer service, cross-functional collaboration, and teamwork skills
  • Proven ability to manage multiple project deliverables and meet project timelines
  • Effective written and verbal communication skills
  • Scientific and analytical evaluation skills US FDA medical device regulations, standards, and guidance
  • 21 CFR 820 - Quality System Regulation.