Profile Details

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USD 150 /hr

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Hire Denise A.

United States

USD 150 /hr

Experienced Regulatory Affairs Professional

Profile Summary

Hi, I'm Denise! I'm a Regulatory Affairs Professional with over 10 years of experience and a Master's Degree in Regulatory Affairs. I have a proven ability to use and apply technical standards, principles, theories, concepts, and techniques. I'm a very dedicated professional who can multi-task and meet or exceed deadlines. I have an impeccable ability to learn quickly and excel. I operate with a strong sense of urgency and thrive in a fast-paced setting. I am experienced in global regulatory filings (Including U.S. and EU) for Class I, Class II, Class IIa & Class III medical devices.

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Premarket Notification/510(k) Submission

Services

• Writing

Writing Technical Writing

Work Experience

Senior regulatory affairs specialist

Silk Road Medical

October 2020 - Present

Senior regulatory affairs specialist

Tosoh Bioscience

April 2018 - October 2020

Senior regulatory affairs specialist

Penumbra Inc

March 2016 - April 2019

REGULATORY ASSOCIATE

Gilead Sciences

February 2014 - March 2016

Education

Masters of Science

The George Washington University

June 2014 - June 2016

Certifications

• Certification details not provided.