Senior Regulatory Affairs Specialist

Job Title:Senior Regulatory Affairs Specialist Location: Santa Clara, CA - 100% Onsite 12 Months Contract + Extensione Pay Range: $60/hr to $66/hr on W2 Job Description: Work with multiple business units to develop, update, and improve regulatory affairs processes that support product registration and ongoing compliance. Assist regulatory affairs strategy implementation and operations, including directing development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports. Update and develop regulatory affairs procedures to support changes in the regulatory landscape, including EU MDR. Identify opportunities to strengthen regulatory affairs processes and drive improvements through completion. Support internal and external inspections by coordinating regulatory documentation and cross-functional readiness activities. What's Needed? 3–5 years of experience in Medical Device Regulatory Affairs. Working knowledge of EU MDR. Working knowledge of Regulatory Change Assessment. Working knowledge of US and EU medical device submissions. Experience supporting internal and external inspections, with the ability to work cross-functionally in a matrixed environment ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law. #J-18808-Ljbffr ManpowerGroup