Senior Regulatory Affairs Specialist
the Client•Santa Clara, CA
•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 regulatory affairs strategy implementation and operations, including directing development of product registration submissions, progress reports, supplements, amendments, and periodic experience reports. The specialist will update and develop procedures to address changes in the regulatory landscape, including EU MDR, identify process improvement opportunities, and drive changes through completion.
Requirements
- Bachelor's 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.
- Applicants must be authorized to work for any employer in the U.S.; visa sponsorship or transfer is unavailable.
Responsibilities
- Work with multiple business units to develop, update, and improve regulatory affairs processes.
- Assist with implementation of regulatory affairs strategy and 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 regulatory affairs process improvement opportunities and drive changes to completion.
Benefits
- Medical insurance
- Vision insurance
- Dental insurance
- 401(k) retirement fund
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What This Job Offers
Career Level
Senior
