Peggy Carter

Peggy Carter Email and Phone Number

Corporate VP Regulatory, Caris Life Science @ Caris Life Sciences
Peggy Carter's Location
Tempe, Arizona, United States, United States
Peggy Carter's Contact Details

Peggy Carter work email

Peggy Carter personal email

About Peggy Carter

I have over ten years of In Vitro Diagnostic industry experience with a broad knowledge of Molecular Biology and Biochemistry in the IVD regulated environment. The focus of the last six years has been on in vitro companion diagnostic devices. I have a proven track record of premarket submissions including 510(k)s for five products within three years. I have successfully submitted both original PMA and PMA supplements (180 and 30 day). I also have experience with pre-IDE and IDE submissions and other FDA communications and face to face meetings . I enjoy working in a results oriented environment facilitating the design of innovative and quality products that improve the lives of patients.Specialties: PMA and 510(k) submission, Pre-IDE, IDEQuality Systems (ISO 13485, 21 CFR 820)Design Control98/79/EC (IVDD)

Peggy Carter's Current Company Details
Caris Life Sciences

Caris Life Sciences

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Corporate VP Regulatory, Caris Life Science
Peggy Carter Work Experience Details
  • Caris Life Sciences
    Corporate Vp Regulatory
    Caris Life Sciences Sep 2022 - Present
    Irving, Texas, Us
  • Novartis
    Vp, Head Regulatory Affairs, Medical Devices Ra Precision Medicine At Novartis
    Novartis Feb 2022 - Sep 2022
    Basel, Baselstadt, Ch
    Leading a dynamic team focused on medical devices/diagnostics regulatory strategy supporting therapeutics development.
  • Novartis
    Vp, Head Regulatory Affairs, Medical Devices
    Novartis Dec 2018 - Jun 2022
    Basel, Baselstadt, Ch
  • Novartis Oncology Development Cdx
    Global Head Drug Regulatory Affairs
    Novartis Oncology Development Cdx Sep 2014 - Sep 2022
  • Novartis Oncology Development Cdx
    Senior Director Regulatory Affairs
    Novartis Oncology Development Cdx Mar 2014 - Sep 2022
  • Novartis Molecular Diagnostics
    Director Regulatory Affairs
    Novartis Molecular Diagnostics Jan 2011 - Sep 2022
  • Ventana Medical Systems, Inc
    Senior Manager, Regulatory Affairs
    Ventana Medical Systems, Inc Jan 2006 - Dec 2010
    Tucson, Arizona, Us
    Responsibilities: Serve on Development Core Teams to provide regulatory, design control, and scientific assistance to facilitate the development of products within the aggressive timelines needed. Oversee the technical file initiative project to update technical files in support of CE marking products. Prepare and submit PMA, 510(k), pre-IDE or other regulatory filings as needed to support marketing, product development, and manufacturing. Serve as a member on Ventana's Safety Board to assist in the evaluation of potential adverse incidents for reportability and product non-conformances or failures for potential correction and removal actions.
  • Ventana Medical Systems, Inc
    Senior Manager, Regulatory Affairs
    Ventana Medical Systems, Inc 2006 - Dec 2010
    Tucson, Arizona, Us
  • R2 Diagnostics
    Director Product Development
    R2 Diagnostics Nov 2002 - Feb 2006
    In conjunction with Enzyme Research Laboratories, r2 DIAGNOSTICS focuses on the production of high quality innovative products for the hemostasis market. Using highly purified and well characterized source proteins and materials, r2 DIAGNOSTICS produces reagents for routine coagulation testing with a major emphasis on the detection of thrombophilia.
  • Biopool Us, Inc
    Process Development Engineer
    Biopool Us, Inc Jan 2001 - Jan 2002
  • Norris Cancer Center
    Research Associate/Post-Doctoral Fellow
    Norris Cancer Center Jan 2000 - Jan 2001
  • University Of Southern California/Norris Cancer Center
    Research Laboratory Specialist
    University Of Southern California/Norris Cancer Center Jan 1999 - Jan 2000
  • Louisiana State University Health Sciences Center/Feistweiller Cancer Center
    Doctoral Fellow
    Louisiana State University Health Sciences Center/Feistweiller Cancer Center Jan 1998 - Jan 1999
  • Louisiana State University Health Sciences Center
    Graduate Assistant
    Louisiana State University Health Sciences Center Jan 1993 - Jan 1998
    Dissertation: Translation initiation at CUG codons enhanced by eIF4E: implications for cancer progression. Mentor: Arrigo De Benedetti, Ph.D
  • Overton Brooks Va  Medical Center
    Research Scientist
    Overton Brooks Va Medical Center Jan 1992 - Jan 1993
  • Endotech Corporation
    Research Scientist
    Endotech Corporation Jan 1990 - Jan 1991

Peggy Carter Skills

Fda Regulatory Affairs Medical Devices Design Control Biotechnology Iso 13485 Molecular Biology Quality System Ivd Validation Gmp In Vitro Diagnostics U.s. Food And Drug Administration Pma Biochemistry Regulatory Submissions Quality Auditing Cancer Glp Ce Marking Hardware Diagnostics Corrective And Preventive Action Ide Capa Quality Control Premarket Approval 510 K Quality Systems Qsr Pre Ide

Peggy Carter Education Details

  • Regulatory Affairs Professionals Society
    Regulatory Affairs Professionals Society
    Us
  • Louisiana State University Health Sciences Center
    Louisiana State University Health Sciences Center
    Biochemistry And Molecular Biology
  • Earlham College
    Earlham College
    Biology

Frequently Asked Questions about Peggy Carter

What company does Peggy Carter work for?

Peggy Carter works for Caris Life Sciences

What is Peggy Carter's role at the current company?

Peggy Carter's current role is Corporate VP Regulatory, Caris Life Science.

What is Peggy Carter's email address?

Peggy Carter's email address is pe****@****tis.com

What schools did Peggy Carter attend?

Peggy Carter attended Regulatory Affairs Professionals Society, Louisiana State University Health Sciences Center, Earlham College.

What skills is Peggy Carter known for?

Peggy Carter has skills like Fda, Regulatory Affairs, Medical Devices, Design Control, Biotechnology, Iso 13485, Molecular Biology, Quality System, Ivd, Validation, Gmp, In Vitro Diagnostics.

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