Senior Regulatory Affairs Specialist

Contract: Plymouth, Minnesota, US

Salary: $60.00 Per Hour

Job Code: 331945

End Date: 2023-04-24

Job Status: Expired

This Job is no longer accepting applications

To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL -, email your updated resume at Email - or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

Years' Experience: 

  • 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 in
  • Have working knowledge in US and EU medical device submissions
  • Have experience supporting internal and external inspections
  • Work cross-functionally and in a matrixed environment
  • Have experience with continuous improvement activities



  • BA Degree Required


  • 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. 


Manager Comments:

  • Prior Regulatory submission experience. 
  • Cardiovascular medical device experience required. 
  • Reviewing Change Assessment.
  • Regulatory Submission.
  • Responsible for doing international work for regulatory affairs.
  • Having submission writing experience and reviewing submission documents and reviewing protocols and reports
  • Assess manufacturing changes


Job Requirement
  • Regulatory Affairs Specialist
  • Regulatory Affairs
  • Change Assessment
  • Regulatory Submission
  • submission writing
  • EU MDR
  • MDR
  • product registration
  • medical device
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