Ellen Karges, Ms

Ellen Karges, Ms Email and Phone Number

Safe Health, LLC @ SAFE Health
Ellen Karges, Ms's Location
Youngstown, Ohio, United States, United States
Ellen Karges, Ms's Contact Details

Ellen Karges, Ms work email

Ellen Karges, Ms personal email

About Ellen Karges, Ms

With over 30 years experience in the quality aspects of diagnostic/research laboratories, 10 years in the medical device/Ivdd regulatory(european/US) systems, leading teams to find strategic pathways to regulatory compliance- leading to CE labels, FDA submissions, diagnostic and clinical trial compliance.

Ellen Karges, Ms's Current Company Details
SAFE Health

Safe Health

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Safe Health, LLC
Ellen Karges, Ms Work Experience Details
  • Safe Health
    Executive Vice President Of Quality And Regulatory Affairs
    Safe Health Jun 2022 - Present
    Scottsdale, Arizona, Us
    View
  • Centogene Ag
    Vp Of Pharmaceutical Compliance
    Centogene Ag Feb 2019 - Present
    Rostock, Mecklenburg-West Pomerania, De
    View
  • Centogene Ag
    Senior Vice President Of Pharmaceutical Compliance
    Centogene Ag Mar 2020 - Jun 2020
    Rostock, Mecklenburg-West Pomerania, De
    View
  • Centogene, Ag
    Sr. Director Of Quality And Member Of Extended Management
    Centogene, Ag Sep 2012 - Present
    Responsible for the entire development of the Quality system at Centogene-Accomplishing CAP/CLIA accreditation-ISO 15189 and completed the CE Label of medical/in vitro devices(over 60 products). Project management of Gepado implementation(LIS) Strengths-Leadership, bringing the right group of people together to complete tasks within given timelines-mentoring and facilitating interpersonal growths. Certified lead auditor(ISO 13485)-member of ASQ. FDA Medical Device and IVDD 510(k)s, DeNovo and PMA experience- GMP/GLP/GCP knowledge and implementation specialist- MDSAP implementation.
  • Freelance
    Senior Consultant
    Freelance May 2022 - May 2022
  • Discovery Life Sciences
    Senior Vice President Of Global Quality And Regulatory Affairs
    Discovery Life Sciences Jun 2020 - May 2022
    Huntsville, Alabama, Us
    View
  • Discovery Life Sciences
    Senior Vice President
    Discovery Life Sciences Jun 2020 - May 2022
    Huntsville, Alabama, Us
    View
  • Colorado Gi Pathology
    Operations Manager
    Colorado Gi Pathology Apr 2006 - Apr 2009

Ellen Karges, Ms Skills

Project Management Quality System Process Improvement Management Business Process Quality Management Quality Assurance Leadership Molecular Biology Ce Marking Cross Functional Team Leadership Fda Gmp Iso 13485 Cap/clia Accreditation Pharmaceutical Industry Fda Md Sap Biotechnology Life Sciences Medical Devices Validation Clinical Trials U.s. Food And Drug Administration Clinical Research Strategy Good Manufacturing Practice Standard Operating Procedure Accreditation Quality Auditing Regulatory Compliance Regulatory Affairs Research

Frequently Asked Questions about Ellen Karges, Ms

What company does Ellen Karges, Ms work for?

Ellen Karges, Ms works for Safe Health

What is Ellen Karges, Ms's role at the current company?

Ellen Karges, Ms's current role is Safe Health, LLC.

What is Ellen Karges, Ms's email address?

Ellen Karges, Ms's email address is el****@****ene.com

What skills is Ellen Karges, Ms known for?

Ellen Karges, Ms has skills like Project Management, Quality System, Process Improvement, Management, Business Process, Quality Management, Quality Assurance, Leadership, Molecular Biology, Ce Marking, Cross Functional Team Leadership, Fda Gmp.

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