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Senior Regulatory Associate

Redmond, WA 98052

Posted: 11/05/2018 Employment Type: Contract Industry: Software Job Number: 19082

Position Title: Senior Regulatory Associate

Position Description: Protingent has an opportunity for a Senior Regulatory Associate in Redmond, WA.

Job Qualifications:                                                                           
  • Bachelor’ s degree in Engineering, Biological Sciences or Allied Health Care.
  • 5+ years of applicable Regulatory/Clinical experience.
  • Thorough understanding of: FDA medical device regulations, guidance, and import/exports requirements, labeling and promotional requirements; medical device quality systems; Product development processes; and clinical trial study design.        
  • Experience managing regulatory submissions including FDA 510(k), IDE, Design Dossiers and Internal “ Letters to File”
  • Proficient with timely review of technical and clinical data
  • Experience negotiating with FDA on products and projects                      

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.

Jeff Morgante

I have an ability to connect with engineers easily, with an engineering background myself, I can relate and communicate using the same language. I have been working in Technical staffing at Protingent since 2011. I have two dogs, Kaleb & Kayce and two cats, Mika and Shiloh. I am originally from upstate New York, but love living in the Pacific Northwest! I have a passion for cars, old and new.

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