Carrie B. Berge

Carrie B. Berge Email and Phone Number

Senior Program Lead Regulatory Affairs at Sterilmed, a Johnson & Johnson Company
Carrie B. Berge's Location
Wyoming, Minnesota, United States, United States
Carrie B. Berge's Contact Details

Carrie B. Berge work email

Carrie B. Berge personal email

n/a
About Carrie B. Berge

Quality Assurance and Regulatory Affairs professional with proven accomplishments in the Medical Device and Medical Food industries. Expertise in domestic and international regulations and standards including FDA QSRs/GMPs, MDD, CMDCAS, ISO 13485, CE Marking, ISO 14971, and Quality Management System development. A team leader with exceptional communication, relationship building and project management skills.

Carrie B. Berge's Current Company Details

Senior Program Lead Regulatory Affairs at Sterilmed, a Johnson & Johnson Company
Carrie B. Berge Work Experience Details
  • Sterilmed, A Johnson & Johnson Company
    Contractor - Regulatory Affairs Specialist
    Sterilmed, A Johnson & Johnson Company May 2017 - Dec 2018
    View
  • Medavise
    Regulatory Affairs And Quality Systems Consultant
    Medavise 2016 - 2018
    View
  • Consultant
    Regulatory Affairs And Quality Systems Consultant
    Consultant 2015 - 2017
  • Exos Llc, A Djo Global Company
    Quality Assurance And Regulatory Compliance Manager
    Exos Llc, A Djo Global Company 2010 - 2015
  • I-Tek Medical Technologies
    Quality Manager
    I-Tek Medical Technologies 2009 - 2010
    formerly Enova Medical Technologies contract manufacturing
  • Enova Medical Technologies
    Quality Manager
    Enova Medical Technologies 2007 - 2009
    Manufacturer of Battery Operated LED Surgical Headlights and Contract Manufacturer of Medical Devices
  • Synovis Interventional Solutions
    Project Manager
    Synovis Interventional Solutions 2005 - 2007
    Managed projects involving the design and development of medical devices.
    View
  • Viasys Healthcare - Pulmonetic Systems
    Documentation Coordinator Supervisor
    Viasys Healthcare - Pulmonetic Systems 2003 - 2005
    Developed, coordinated and maintained the document control system. Prepared and processed engineering change orders (ECO's).
    View
  • Qwest Communications
    Sr. Process Analyst
    Qwest Communications 2000 - 2002

Carrie B. Berge Skills

Quality System Regulatory Affairs Iso 13485 Fda Capa Iso 14971 Design Control Gmp Fda Gmp Quality Auditing V&v Iso Medical Devices 21 Cfr Validation Supplier Quality Quality Assurance Project Management

Carrie B. Berge Education Details

Frequently Asked Questions about Carrie B. Berge

What is Carrie B. Berge's role at the current company?

Carrie B. Berge's current role is Senior Program Lead Regulatory Affairs at Sterilmed, a Johnson & Johnson Company.

What is Carrie B. Berge's email address?

Carrie B. Berge's email address is cb****@****cal.com

What schools did Carrie B. Berge attend?

Carrie B. Berge attended University Of St. Thomas - Opus College Of Business, Gustavus Adolphus College, University Of Minnesota-Twin Cities.

What skills is Carrie B. Berge known for?

Carrie B. Berge has skills like Quality System, Regulatory Affairs, Iso 13485, Fda, Capa, Iso 14971, Design Control, Gmp, Fda Gmp, Quality Auditing, V&v, Iso.

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