Dr. Carrie [Kuehn] Huffman, RAC-US

Regulatory Advisory Board Member, Signify
Washington DC-Baltimore Area,United States
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Who Is Dr. Carrie [Kuehn] Huffman, RAC-US?

Total Experience22 years
CompanySignify
CountryUnited States

Dr. Carrie Kuehn Huffman is a highly accomplished and seasoned regulatory affairs executive with extensive experience in the pharmaceutical, biotechnology, and medical device industries. Holding the RAC-US certification, she possesses deep expertise in navigating complex U.S. FDA regulatory pathways, developing and executing global regulatory strategies, and managing all phases of product development from pre-clinical through post-market surveillance. Her proficiency includes preparing and managing INDs, NDAs, BLAs, 510(k)s, PMAs, and De Novo submissions. Dr. Huffman is recognized for her ability to provide strategic guidance, lead cross-functional teams, and effectively liaise with regulatory agencies to achieve successful product approvals and maintain compliance.

Dr. Carrie [Kuehn] Huffman, RAC-US LinkedIn pageCompany Website

How Did Dr. Carrie [Kuehn] Huffman, RAC-US's Career Path Shape Their Journey?

Dr. Carrie [Kuehn] Huffman, RAC-US's work history includes a series of influential roles in various companies. Here is a detailed list of his professional journey:

Signify - Regulatory Advisory Board Member(2024 to Present)
Evergreen Strategic Consulting - Principal Consultant & Founder(2019 to Present)
Liquet Medical Inc. - Head of Regulatory(2024 to Present)
Temple University School of Pharmacy - Adjunct Assistant Professor - RAQA Graduate Program(2024 to Present)
The Hong Kong University of Science and Technology - Adjunct Assistant Professor - Drug Regulatory Affairs and Policy (DRAP) Program(2024 to 2024)
Northeastern University College of Professional Studies - Part-Time Lecturer Medical Device Regulatory Affairs(2017 to 2024)
Exactech - Senior Director Clinical Affairs(2022 to 2023)
Evidation Health - Senior Manager, Regulatory and Clinical(2020 to 2021)
Novateur Ventures Inc. - Regulatory Advisor(2019 to 2020)
Edwards Lifesciences LLC - Lead, Patient Science & Engagement(2018 to 2019)

What Are Dr. Carrie [Kuehn] Huffman, RAC-US's Key Achievements?

RAC-US Certification

Earned the Regulatory Affairs Certification (US), demonstrating comprehensive knowledge and expertise in U.S. healthcare product regulations for drugs, biologics, and medical devices.

Leadership in Regulatory Strategy

Successfully led and developed numerous regulatory strategies for novel and established products, resulting in timely FDA approvals and market access for innovative therapies and devices.

Successful FDA Submissions & Interactions

Proven track record of managing and authoring successful submissions to the FDA, including complex applications, and effectively leading interactions and negotiations with the agency.

Development of Compliant Quality Systems

Instrumental in establishing and enhancing quality management systems to ensure adherence to cGMP, QSR, and other relevant regulatory standards across multiple organizations.

What's Dr. Carrie [Kuehn] Huffman, RAC-US's Educational Background?

Doctor of Law and Policy

Northeastern University - Year 2015

MPH, Epidemiology

University of Washington - Year 2001

MA, Biocultural (Physical) Anthropology

University of Washington - Year 2000

BA, Anthropology

University of Washington - Year 1993

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Company Overview

Signify
Total employees35000
HeadquartersEindhoven
Founded2016

Signify (formerly Philips Lighting) is the world leader in lighting for professionals, consumers, and lighting for the Internet of Things. Their energy-efficient lighting products, systems, and services enable customers to enjoy a superior quality of light, making people’s lives safer and more comfortable, businesses more productive, and cities more livable. Signify is committed to sustainability and aims to unlock the extraordinary potential of light for brighter lives and a better world.

Company Website
Signify Stock Information
Signify, Inc. is listed on the Euronext Amsterdam under the ticker symbol LIGHT. The company went public on May 27, 2016

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