Wenkai 馬雯凱
Director of Regulatory Affairs at AbbVie | Ventura, California, United States
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Wenkai 馬雯凱 serves as the Director of Regulatory Affairs at AbbVie, where he leverages his extensive expertise in regulatory strategy development to navigate the complex landscape of medical device approvals globally. With a robust background in life sciences and engineering, Wenkai is adept at crafting and implementing regulatory strategies that facilitate rapid and cost-effective registrations and licensing of medical devices with international regulatory authorities, including the China FDA, Health Canada, TGA, KFDA, Singapore HSA, and Taiwan's regulatory bodies.
In his current role, Wenkai is responsible for the development of global regulatory strategies and serves as a key representative of Regulatory Affairs on various R&D project teams. His ability to communicate intricate regulatory strategies to cross-functional project teams is pivotal in ensuring that medical device products meet stringent regulatory requirements while advancing through the development pipeline efficiently. Wenkai leads a talented team of regulatory professionals, guiding them in the successful planning and execution of regulatory activities on a worldwide scale.
Wenkai's skill set encompasses a wide range of areas, including clinical research, clinical development, and clinical trials, making him a vital asset in the lifecycle of medical devices from conception to market entry. His expertise in CE marking, IND processes, and validation further enhances his capability to navigate the regulatory landscape effectively. As a thought leader in regulatory affairs, Wenkai is committed to fostering innovation while ensuring compliance, ultimately contributing to AbbVie's mission of delivering transformative therapies to patients around the globe.
Director of Regulatory Affairs at AbbVie in January 2021 to Present
Director of Regulatory Affairs at Medtronic in January 2015 to January 2020
Director, Global Regulatory Affairs at Cerus in January 2013 to January 2015
Director, Global Regulatory Affairs at Allergan in January 2010 to January 2013
Manager Global Regulatory Affairs at Ethicon/Johnson & Johnson in January 2003 to January 2009
Manager at Mentor Corporation, Johnson& Johnson in January 1997 to January 2003
Scientist at Baxter Bioscience in January 1996 to January 1997
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University of Utah
Asian Institute of Technology, ME
Beijing University of Technology, BS
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Regulatory Strategy Development
Regulatory Submissions
Regulatory Affairs
FDA
Medical Devices
Lifesciences
Clinical Research
Clinical Development
GMP
Clinical Trials
CAPA
Regulatory Requirements
CE marking
Strategy
Validation
ISO 13485
IND
V&V
Life Sciences
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Discover more about AbbVieWhat is Wenkai 馬雯凱 email address?
Email Wenkai 馬雯凱 at [email protected] and [email protected]. This email is the most updated Wenkai 馬雯凱's email found in 2026.
How to contact Wenkai 馬雯凱?
To contact Wenkai 馬雯凱 send an email to [email protected] or [email protected]. (updated on March 14, 2021)
What company does Wenkai 馬雯凱 work for?
Wenkai 馬雯凱 works for AbbVie
What is Wenkai 馬雯凱's role at AbbVie?
Wenkai 馬雯凱 is Director of Regulatory Affairs
What is Wenkai 馬雯凱's Phone Number?
Wenkai 馬雯凱's phone (213) ***-*144
What industry does Wenkai 馬雯凱 work in?
Wenkai 馬雯凱 works in the Medical Devices industry.
Wenkai 馬雯凱 Email Addresses
Wenkai 馬雯凱 Phone Numbers
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