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