Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-11025
  • Location: Minneapolis Minnesota (MN) 55442
  • Posted Date: 02/11/2021
  • Duration: 8 Months
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  Job Description

This is a 100% remote role

Minimum of 2 years in regulatory, preferably 3-4 yeas of experience

Top skills:

  • Understanding and actual submission experience
  • Regulatory experience
  • Strong communication skills
  • Engineering Change orders and labeling

Updates from Manager

  • EU submission experience required
  • Experience working with engineering change orders
  • No school experience or academic experience will work for this role
  • Need to have actual submission experience
  • Bachelor’s degree or master’s degree needed or any science degree
  • This role is 100% remote
  • Hosting meeting and be a leadership voice would be nice to have
  • Class 3 medical device experience is a plus
  • Pharma industry experience will not work
  • Someone who is well organized
  • Providing documents that they need
  • US, EU, international submission is a requirement
  • Project is working on EUMDR changing regulations
  • Looking for 2 regulatory contractors to join this project
  • Some EUMDR experience is nice to have
  • Individual will be conducting worldwide changes to product
  • Tracking submissions
  • Good with excel and projects and documenting
  • EUMDR understanding
  • Any direct submission experience is also nice to have
  • Candidates will be remote
  • If the candidate is in MN local that would be great but open for remote candidates as well
  • Hands on regulatory submission experience
  • Good communication skills
  • 50% international and 30% EUMDR 10% in US side as well, 10% on engineering side
  • Doing submission in Asia pacific, Canada, Asia, south Asia, Latin America