Senior Regulatory Affairs Specialist (Remote)

Contract: Minneapolis, Minnesota, US

Salary: $60.00 Per Hour

Job Code: 330407

End Date: 2023-04-25

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 - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Job Description:
Job Roles & Responsibilities:

  • Science related Bachelor’s Degree required
  • 2+ years of regulatory experience in med device highly preferred
  • Preferred local candidates – hybrid two a week, but open to remote
  • Assist with transcatheter heart valve line
  • Post market type activities and manufacturing operations
  • Reviewing change requests
  • Update product documents
  • Determine regulatory changes for EEUS and other geographies
  • Request changes to processes if required
  • Assisting with suppliers or adding new suppliers
  • Order requests for FDA post market reports
  • Someone with manufacturing, change orders, regulatory experience – some submission writing experience a plus
  • Writing submissions possible – month reports
Job Requirement
  • Regulatory Affairs Specialist
  • Regulatory Affairs
  • FDA
  • post market
  • regulatory
  • MDR
  • EU MDR
  • submission
  • Medical Device
Reach Out to a Recruiter
  • Recruiter
  • Email
  • Phone
  • Chitrank Rastogi
  • chitrank.rastogi@collabera.com
  • 4255231648
This Job is no longer accepting applications
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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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Collabera is a leading global digital talent solutions firm. For over 25 years, we have provided digital and IT talent services, direct placement and career advisement, global remote talent and learning solutions to transform and diversify workforces for the Fortune 1000 globally.

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