Senior Regulatory Affairs Specialist # JN -062021-66040

Little Canada, Minnesota
Industry: Regulatory
Job Number: JN -062021-66040

Title                           : Senior Regulatory Affairs Specialist

Location                    : Little Canada, MN, 55117

Duration                   : 6+ months contract

 

Description:

  • Must have 3-5 years of experiences in Medical Device Regulatory Affairs
  • Have working knowledge in EU MDR
  • Have working knowledge in Regulatory Change Assessment
  • Have working knowledge in US and EU medical device submissions
  • Have experience supporting internal and external inspections
  • Have experience with continuous improvement activities

Education:

  • BA Degree Required

 

Duties:

  • This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
  • Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
  • Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
  • Identify opportunity for regulatory affair processes and drive changes to completion. "

 


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