Senior Regulatory Associate
11811 Willows Rd. NE Redmond, WA 98052
Position Title: Senior Regulatory Associate
Position Description: Protingent has an opportunity for a Senior Regulatory Associate in Redmond, WA.
- 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.
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.