Wenkai 馬雯凱 Email & Phone Number

Wenkai 馬雯凱

Director of Regulatory Affairs at AbbVie | Ventura, California, United States

Wenkai 馬雯凱 Socials
About Wenkai 馬雯凱

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.

Wenkai 馬雯凱 Work
1 experience icon

Director of Regulatory Affairs at AbbVie in January 2021 to Present

2 experience icon

Director of Regulatory Affairs at Medtronic in January 2015 to January 2020

3 experience icon

Director, Global Regulatory Affairs at Cerus in January 2013 to January 2015

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Wenkai 馬雯凱 Education

University of Utah

Asian Institute of Technology, ME

Beijing University of Technology, BS

Wenkai 馬雯凱 Skills

Regulatory Strategy Development

Regulatory Submissions

Regulatory Affairs

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About Wenkai 馬雯凱's Current Company
Frequently Asked Questions about Wenkai 馬雯凱

What 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

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.

Wenkai 馬雯凱 Phone Numbers

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