Remote Regulatory Affairs Professional in Flagstaff

Location: Arizona

Compensation: To Be Discussed

Staff Reviewed: Wed, Jan 13, 2021

This job expires in: 17 days

Job Category: Healthcare

Remote Level: Partially Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A manufacturing company has a current position open for a Remote Regulatory Affairs Professional in Flagstaff.

Individual must be able to fulfill the following responsibilities:

  • Coordinating activities and timelines with applicable functional groups to complete regulatory submissions
  • Evaluating product labeling, product claims, advertising, specifications, and changes
  • Interacting closely with and counsel functional groups in the business

Required Skills:

  • Willingness to travel 15%
  • At least 3 years of Regulatory Affairs experience in the medical device industry
  • Experience formulating and implementing regulatory strategies and writing comprehensive regulatory documents
  • Experience proactively identifying necessary submission content and assessing the project documentation
  • Knowledge of FDA and international regulations related to Class II and Class III implantable medical devices
  • Demonstrated success regarding the assessment of proposed changes to medical device design

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