Heather Lambert

Manager Global Regulatory Affairs at Bracco Medical Technologies
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Contact Information
us****@****om
(386) 825-5501
Location
US
Languages
  • English Native or bilingual proficiency
  • French Limited working proficiency
Skills

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Bio

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Lisa Milan

Heather is part of a professional organization that I belong to. I have known Heather for over 6 years, throughout which her talents have been evident repeatedly. Heather is extremely thorough in every thing she takes on. She tackles any challenge with enthusiasm and confidence. Her personal and professional integrity are unmatched. Don't miss out on the chance to work with Heather. She is a true gem.

Elizabeth Kooser

I have had the pleasure of working with Heather at Medtronic. She was a knowledgeable, dedicated and helpful colleague. No matter how busy she was, Heather always made herself available to assist anyone within her area of expertise. Heather would be a great additiona to any employer and would always provide her best!

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Credentials

  • RAC-US
    Regulatory Affairs Certification Program
    Dec, 2015
    - Sep, 2024
  • RAC-US
    Regulatory Affairs Certification Program
    Dec, 2015
    - Sep, 2024
  • RAPS Member
    Regulatory Affairs Certification Program
    Jun, 2015
    - Sep, 2024

Experience

  • Bracco Medical Technologies
    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Manager Global Regulatory Affairs
      • May 2022 - Present

    • Principal Regulatory Affairs Specialist
      • Dec 2019 - May 2022

      International Lead: Manage new product submissions, market expansion and product renewals.

  • Beckman Coulter
    • Biotechnology Research
    • Staff Regulatory Affairs (RAC US)
      • Feb 2016 - Dec 2019

      International Lead: Manage new product submissions, market expansion and product renewals.Contributing member of multi-business unit Global Regulatory Council and Product Labeling Council. Notified Body change and MDSAP readiness.

    • Manager Regulatory Affairs (RAC US)
      • Jun 2014 - Feb 2016

      Global submissions and sustaining legacy product. Create and implement regulatory database and workflow using Trackwise.

    • Senior Analyst Regulatory Affairs
      • Jul 2011 - Jun 2014

      Plan, coordinate, create, and submit document packages to support global regulatory submissions for world-wide marketing approvals. Metric creation and reporting.

  • Medtronic
    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Senior Compliance Specialist
      • Nov 2005 - Jul 2011

      Ensured internal policies and external requirements were being met and followed by 200+ customer facing employees by creating/ delivering training modules and auditing.Applied Lean Sigma techniques as project manager for teams of up to 12 individuals.

    • Consignment Agreement Coordinator
      • Nov 2004 - Nov 2005

      Partnered with business unit supply chain, finance, pricing and contracts, legal and sales management to create new consignment requests, manage changes and renew agreements with customers to ensure compliance to Medtronic’s World-Wide Finance Manual.

    • Customer Service- Account Specialist
      • Oct 2002 - Nov 2004

      Provided superior customer service to field sales staff and external customers by making use of a broad knowledge of Medtronic’s business policies and products.

  • MVAC & Institute for MN Archaeology
    • Sr. Archaeological Technician/ Supervisor
      • Jan 1993 - Jan 2000

      Participated in various archaeological contracts; compiled and analyzed data and drafted technical reports. Trained and supervised students in a laboratory atmosphere and field environment as part of their college degree. Participated in various archaeological contracts; compiled and analyzed data and drafted technical reports. Trained and supervised students in a laboratory atmosphere and field environment as part of their college degree.

Education

  • University of Wisconsin-La Crosse
    Bachelor of Science
    1992 - 1996

Community

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