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Job description
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
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Worksite address
santa clara, CA, 95053, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.