Stephanie Gorman, M.S.

Stephanie Gorman, M.S. Email and Phone Number

Principal Regulatory Affairs Specialist at Boston Scientific @ Boston Scientific
Marlborough
Stephanie Gorman, M.S.'s Location
Townsend, Massachusetts, United States, United States
Stephanie Gorman, M.S.'s Contact Details

Stephanie Gorman, M.S. personal email

n/a
About Stephanie Gorman, M.S.

Experienced Regulatory Affairs Specialist with a demonstrated history of working in the medical device industry. Skilled in U.S. Food and Drug Administration (FDA), Research and Development (R&D), Verification and Validation (V&V), Corrective and Preventive Action (CAPA), and Medical Devices. Strong regulatory professional with a Master's of Science focused in Regulatory Affairs from Northeastern University.

Stephanie Gorman, M.S.'s Current Company Details
Boston Scientific

Boston Scientific

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Principal Regulatory Affairs Specialist at Boston Scientific
Marlborough
Website:
bostonscientific.com
Employees:
10
Company phone:
+1 800-876-9960
Company email:
info@bostonscientific.com
Stephanie Gorman, M.S. Work Experience Details
  • Boston Scientific
    Principal Regulatory Affairs Specialist
    Boston Scientific Sep 2023 - Present
    Marlborough, Ma, Us
    View
  • Boston Scientific
    Sr. Regulatory Affairs Specialist
    Boston Scientific Jun 2019 - Sep 2023
    Marlborough, Ma, Us
    View
  • Insulet Corporation
    Sr. Regulatory Affairs Specialist
    Insulet Corporation Apr 2016 - Jun 2019
    Acton, Massachusetts, Us
    Approve promotional labeling in according with regulations. Prepare submissions (510(k), IDE, IDE reports, Pre-submissions) for the FDA and technical documentation updates according to MDD regulations.Review change in documentation to ensure compliance with applicable regulationsParticipate in internal and external audits
    View
  • Medica Corporation
    Regulatory Affairs Specialist
    Medica Corporation Feb 2016 - Apr 2016
    Bedford, Ma, Us
    View
  • Medica Corporation
    Regulatory Affairs Coordinator
    Medica Corporation Jan 2012 - Feb 2016
    Bedford, Ma, Us
    International Product Registration and FDA Submissions
    View
  • Medica Corporation
    Associate Scientist
    Medica Corporation Sep 2008 - Jan 2012
    Bedford, Ma, Us
    View

Stephanie Gorman, M.S. Skills

Medical Devices Gmp Fda Regulatory Affairs Iso 13485 Product Launch Validation Quality System Capa Product Development R&d V&v Design Control

Stephanie Gorman, M.S. Education Details

  • Northeastern University
    Northeastern University
    Regulatory Affairs
  • Old Dominion University
    Old Dominion University
    General

Frequently Asked Questions about Stephanie Gorman, M.S.

What company does Stephanie Gorman, M.S. work for?

Stephanie Gorman, M.S. works for Boston Scientific

What is Stephanie Gorman, M.S.'s role at the current company?

Stephanie Gorman, M.S.'s current role is Principal Regulatory Affairs Specialist at Boston Scientific.

What is Stephanie Gorman, M.S.'s email address?

Stephanie Gorman, M.S.'s email address is sg****@****let.com

What schools did Stephanie Gorman, M.S. attend?

Stephanie Gorman, M.S. attended Northeastern University, Old Dominion University.

What skills is Stephanie Gorman, M.S. known for?

Stephanie Gorman, M.S. has skills like Medical Devices, Gmp, Fda, Regulatory Affairs, Iso 13485, Product Launch, Validation, Quality System, Capa, Product Development, R&d, V&v.

Who are Stephanie Gorman, M.S.'s colleagues?

Stephanie Gorman, M.S.'s colleagues are Katja Hoffman, Aniruddha Banerji, Nicole Porras, Paige Hauber, Raquel Damcalov, Srivatsan V, Xizhi Wang.

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