Senior Regulatory Affairs Specialist

generis Tek • Santa Clara, CA

22h • Onsite

About The Position

The Senior Regulatory Affairs Specialist will work with multiple business units to develop, update, and improve regulatory affairs processes. The role supports strategy implementation and regulatory affairs operations, including directing the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports. The specialist will update and develop procedures to support changes in the regulatory landscape, including EU MDR, identify opportunities to improve regulatory affairs processes, and drive changes through completion.

This is a 12-month contract role based in Santa Clara, California. The listed schedule is Monday through Friday, 8:00 AM to 5:00 PM, with a pay rate of $62.00 per hour on W2.

Requirements

• Bachelor of Arts degree required.
• 3–5 years of experience in medical device regulatory affairs.
• Working knowledge of EU MDR.
• Working knowledge of regulatory change assessment.
• Working knowledge of U.S. and EU medical device submissions.
• Experience supporting internal and external inspections.
• Ability to work cross-functionally and in a matrixed environment.
• Experience with continuous improvement activities.

Responsibilities

• Work with multiple business units to develop, update, and improve regulatory affairs processes.
• Assist with strategy implementation and regulatory affairs operations.
• Direct 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 improve regulatory affairs processes and drive changes to completion.

What This Job Offers

• Career Level: Senior