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Sinead Burke

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Sinead Burke

Vice President of Regulatory Affairs | Cook Medical

Ireland

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Sinead Burke

Summary

Sinead Burke is an accomplished Vice President of Global Regulatory Affairs at Cook Medical, bringing over 25 years of experience in the medical equipment and supplies manufacturing industry. With a robust background in regulatory affairs, she has successfully led initiatives to ensure compliance with EU MDR across multiple sites. Sinead's expertise in FDA regulations, ISO 13485, CAPA, and design control underpins her strategic leadership in navigating complex regulatory landscapes. She holds a BSc Hons in Chemistry from The Open University and a Certificate in Applied Chemistry from Cork Institute of Technology. Her career trajectory showcases a steady ascent through various roles at Cook Medical, reflecting her deep commitment to the field. Sinead's passion for innovation and emerging technologies positions her as a thought leader in regulatory affairs. Outside of her professional life, she is likely involved in mentoring the next generation of regulatory professionals, sharing her insights and experiences.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Leadership Development

Emerging Technologies

Organisational experience

Corporate Experience

Sinead Burke

Work Experience

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Vice President of Regulatory Affairs at

Cook Medical

December 2021 - Present

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Director Regulatory Affairs, Cook Medical Europe at

Cook Medical

November 2018 - December 2021

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Director Global Regulatory Affairs at

Cook Medical

January 2021 - December 2021

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Director, Regulatory Affairs at

Cook Medical

October 2015 - September 2019

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Regulatory Affairs Manager at

Cook Medical

January 2006 - September 2015

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Production Co-ordinator at Nitrates API facility, Nitrates Manufacturing Chemist at

Schwarz Pharma Api Manufacturer

January 1997 - January 2006

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Sinead Burke

Education

The Open University, Bsc Hons

January 1998 - January 2000

Cork Institute of Technology, Cert In Applied Chemistry

January 1993 - January 1995

Frequently Asked Questions about Sinead Burke

What is Sinead Burke email address?

Sinead Burke's primary email address is ************@cookmedical.com. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Sinead Burke work for?

Sinead Burke is a Vice President of Regulatory Affairs at Cook Medical, a company specializing in Measuring & controlling devices, nec.

Where Sinead Burke graduated from?

Sinead Burke holds a degree in Chemistry from The Open University.

How can I directly contact Sinead Burke?

To contact Sinead Burke directly, you can use the email address ************@cookmedical.com. Complete contact information is available upon registration with Muraena.

Who is Sinead Burke?

Sinead Burke is an accomplished Vice President of Global Regulatory Affairs at Cook Medical, bringing over 25 years of experience in the medical equipment and supplies manufacturing industry. With a robust background in regulatory affairs, she has successfully led initiatives to ensure compliance with EU MDR across multiple sites. Sinead's expertise in FDA regulations, ISO 13485, CAPA, and design control underpins her strategic leadership in navigating complex regulatory landscapes. She holds a BSc Hons in Chemistry from The Open University and a Certificate in Applied Chemistry from Cork Institute of Technology. Her career trajectory showcases a steady ascent through various roles at Cook Medical, reflecting her deep commitment to the field. Sinead's passion for innovation and emerging technologies positions her as a thought leader in regulatory affairs. Outside of her professional life, she is likely involved in mentoring the next generation of regulatory professionals, sharing her insights and experiences.

Sinead`s contact details

mail

************@cookmedical.com

*************@eircom.net

Colleagues

Scott Sewell

Vice President External Affairs

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Pat Burke

Vice President & General Manager

Amber Beauchamp

Vice President Global Human Resources

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Greg Mullinax

Chief Operating Officer Cook Medical Japan

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Gretchen Gutman

Vice President of Public Policy

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Gretchen Gutman

Vice President Public Policy

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Rob Dorocke

Vice President, Global IT Strategies

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Robert Popp

VP, Quality Cook Medical

Thomas Connaughton

Vice President

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Andy Cron

Vice President Critical Care, MedSurg Division

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