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Ellen Karges Ms

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Ellen Karges Ms

Executive Vice President of Quality and Regulatory Affairs | Safe Health

Youngstown, Ohio, United States

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Ellen Karges Ms

Summary

Ellen Karges is a seasoned professional with over 30 years of experience in the quality management aspects of diagnostic and research laboratories. She has spent a decade specializing in regulatory systems for medical devices and in vitro diagnostics across both European and U.S. markets. Ellen is known for her strategic leadership in navigating complex regulatory pathways, resulting in successful FDA submissions and CE markings for numerous products. Her expertise spans a wide range of areas including quality assurance, regulatory compliance, and project management. Ellen is a certified lead auditor for ISO 13485 and has a proven track record in mentoring teams and fostering interpersonal growth. With a history of working in both startup and corporate environments, she brings a unique blend of adaptability and specialized knowledge. Ellen holds a pivotal role in her current organization, where she continues to influence the field of medical laboratories and biotechnology.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Industry-specific interests

Leadership Development

Innovation

Organisational experience

Corporate Experience

Consulting Experience

Ellen Karges Ms

Work Experience

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Executive Vice President of Quality and Regulatory Affairs at

Safe Health

June 2022 - Present

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VP of Pharmaceutical Compliance at

CENTOGENE

February 2019 - Present

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Sr. Director of Quality and member of Extended Management at

Centogene

September 2012 - Present

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Senior Consultant at

Freelance

May 2022 - May 2022

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Senior Vice President at

Discovery Life Sciences

June 2020 - May 2022

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Senior Vice President of Global Quality and Regulatory Affairs at

Discovery Life Sciences

June 2020 - May 2022

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Senior Vice President of Pharmaceutical Compliance at

CENTOGENE

March 2020 - June 2020

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Operations Manager at

Colorado Gi Pathology

April 2006 - April 2009

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Frequently Asked Questions about Ellen Karges Ms

What is Ellen Karges Ms email address?

Ellen Karges Ms's primary email address is ************@safehealth.me. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Ellen Karges Ms work for?

Ellen Karges Ms is a Executive Vice President of Quality and Regulatory Affairs at Safe Health, a company specializing in Specialty hospitals, except psychiatric.

How can I directly contact Ellen Karges Ms?

To contact Ellen Karges Ms directly, you can use the email address ************@safehealth.me. Complete contact information is available upon registration with Muraena.

Who is Ellen Karges Ms?

Ellen Karges is a seasoned professional with over 30 years of experience in the quality management aspects of diagnostic and research laboratories. She has spent a decade specializing in regulatory systems for medical devices and in vitro diagnostics across both European and U.S. markets. Ellen is known for her strategic leadership in navigating complex regulatory pathways, resulting in successful FDA submissions and CE markings for numerous products. Her expertise spans a wide range of areas including quality assurance, regulatory compliance, and project management. Ellen is a certified lead auditor for ISO 13485 and has a proven track record in mentoring teams and fostering interpersonal growth. With a history of working in both startup and corporate environments, she brings a unique blend of adaptability and specialized knowledge. Ellen holds a pivotal role in her current organization, where she continues to influence the field of medical laboratories and biotechnology.

Ellen`s contact details

mail

************@safehealth.me

************@centogene.com

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