プロフィール詳細

プロジェクトを作成

★★★★★

☆☆☆☆☆

★★★★★

☆☆☆☆☆

Denise A.に依頼

United States

Experienced Regulatory Affairs Professional

プロフィール概要

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.

専門分野

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

サービス

• Writing

Writing Technical Writing

職務経験

Senior regulatory affairs specialist

Silk Road Medical

10月 2020 - 現在

Senior regulatory affairs specialist

Tosoh Bioscience

4月 2018 - 10月 2020

Senior regulatory affairs specialist

Penumbra Inc

3月 2016 - 4月 2019

REGULATORY ASSOCIATE

Gilead Sciences

2月 2014 - 3月 2016

学歴

Masters of Science

The George Washington University

6月 2014 - 6月 2016

認定資格

• 認定資格の詳細は未入力です。