Senior Regulatory Affairs Specialist

Kyyba • Santa Clara, CA

9h

About The Position

The Senior Regulatory Affairs Specialist will work with multiple business units to develop, update, and improve regulatory affairs processes. The role assists with strategy implementation and the operation of regulatory affairs activities, including directing the development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports. The specialist also updates and develops procedures to support changes in the regulatory landscape, including EU MDR, and identifies opportunities to improve regulatory affairs processes and drives changes through completion. The position is located in Santa Clara, California.

Requirements

• 3–5 years of experience in medical device regulatory affairs.
• Bachelor of Arts degree required.
• 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 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 operations for regulatory affairs activities.
• Direct the development of product registration submissions, progress reports, supplements, amendments, or 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.
• Support internal and external inspections.

Benefits

• Medical, dental, and vision coverage.
• 401(k).
• Term life insurance.
• Voluntary life and disability insurance.
• Optional prepaid legal plan.
• Optional identity theft plan.
• Optional medical and dependent care FSA.
• Work-visa sponsorship.
• Opportunity for advancement.
• Long-term assignment with opportunity for hire by the client.
• Career development.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior