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Remote Senior Healthcare Regulatory Affairs Specialist

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Thu, Jan 14, 2021
Job Category: Government
Weekly Hours: Full Time
Employer Type: Employer
Career Level: Experienced
Education Level: Bachelors

Job Summary

A software development company has a current position open for a Remote Senior Healthcare Regulatory Affairs Specialist.

Candidates will be responsible for the following:

  • Preparing comprehensive regulatory strategies for new devices
  • Compiling materials for license renewals, updates and registrations
  • Maintaining regulatory files/database and chronologies in good order

Required Skills:

  • A BA degree in a science or related field
  • 5 years relevant experience within the regulatory affairs discipline
  • Knowledge of US and international medical device regulatory requirements
  • Experience with DeNovo devices is mandatory
  • Participation in Breakthrough Device Classification
  • Experience with a Quality Management System (QMS) like Greenlight Guru

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