Regulatory Affairs Specialist

1 month ago


Portage, Michigan, United States Comrise Full time
Job Title: Labeling and Regulatory Affairs Specialist

This is an 18-month contract position with a high possibility of extension.

Key Responsibilities:

  • Execute complex tasks associated with support of medical device labeling development and maintenance.
  • Pull data from our quality system to upload IFUs to our eIFU website.
  • Work with partners regarding supplemental labeling, including communication management, forms, and deep data dives.
  • Perform miscellaneous tasks for our team as needed.
  • Experience with one PLM is preferred, and prior experience with labeling is also preferred.

Requirements:

  • Strong understanding of regulatory affairs and labeling principles.
  • Excellent communication and project management skills.
  • Ability to work independently and as part of a team.

What We Offer:

  • A competitive hourly rate of $24 to $26.
  • A dynamic and supportive work environment.


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