Andrea Wallen-Gerding

Andrea Wallen-Gerding Email and Phone Number

Principal Regulatory Affairs Specialist at Stryker Instruments @ Stryker
kalamazoo, michigan, united states
Andrea Wallen-Gerding's Location
Howell, Michigan, United States, United States
Andrea Wallen-Gerding's Contact Details

Andrea Wallen-Gerding personal email

n/a
About Andrea Wallen-Gerding

Experienced Regulatory Affairs Specialist with a demonstrated history of working in the medical device industry. Skilled in FDA Medical Device Submissions, CE Marking, International Product Registrations, Design Controls, Verification and Validation (V&V), Failure Mode and Effects Analysis (FMEA), Quality System Compliance, and Quality Management. Strong program and project management professional graduated from University of Michigan-Dearborn.

Andrea Wallen-Gerding's Current Company Details
Stryker

Stryker

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Principal Regulatory Affairs Specialist at Stryker Instruments
kalamazoo, michigan, united states
Website:
stryker.com
Employees:
37289
Andrea Wallen-Gerding Work Experience Details
  • Stryker
    Principal Regulatory Affairs Specialist
    Stryker Jul 2015 - Present
    Kalamazoo, Michigan Area
    View
  • Delphinus Medical Technologies, Inc.
    Director Of Quality And Regulatory Affairs
    Delphinus Medical Technologies, Inc. Jun 2011 - Mar 2015
    Plymouth, Michigan
    View
  • Syncardia Systems, Inc.
    Senior Quality Engineer
    Syncardia Systems, Inc. Oct 2010 - Dec 2011
    Tucson, Arizona Area
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  • Terumo Cardiovascular Systems
    Regulatory Affairs Specialist
    Terumo Cardiovascular Systems Feb 2006 - Oct 2010
    Ann Arbor, Michigan
  • Pall Life Sciences
    Associate Product Development Engineer
    Pall Life Sciences Feb 2002 - Feb 2006

Andrea Wallen-Gerding Skills

Iso 13485 Iso 14971 21 Cfr Part 11 Risk Management Fmea 21 Cfr Part 800 Biocompatibility Quality System Compliance Quality Management Supplier Quality Medical Device Directive Reach Rohs Weee Directive 2007/47/ec Council Directive 93/42/eec Council Directive 90/385/eec Fda Medical Devices Design Control V&v Capa Software Verification Software Validation Project Management Project Planning Pmas Ide Clinical Trials Regulatory Affairs Testing Quality System Validation Product Development Failure Mode And Effects Analysis Verification And Validation

Andrea Wallen-Gerding Education Details

Frequently Asked Questions about Andrea Wallen-Gerding

What company does Andrea Wallen-Gerding work for?

Andrea Wallen-Gerding works for Stryker

What is Andrea Wallen-Gerding's role at the current company?

Andrea Wallen-Gerding's current role is Principal Regulatory Affairs Specialist at Stryker Instruments.

What is Andrea Wallen-Gerding's email address?

Andrea Wallen-Gerding's email address is aw****@****smt.com

What schools did Andrea Wallen-Gerding attend?

Andrea Wallen-Gerding attended University Of Michigan-Dearborn, University Of Michigan-Dearborn.

What skills is Andrea Wallen-Gerding known for?

Andrea Wallen-Gerding has skills like Iso 13485, Iso 14971, 21 Cfr Part 11, Risk Management, Fmea, 21 Cfr Part 800, Biocompatibility, Quality System Compliance, Quality Management, Supplier Quality, Medical Device Directive, Reach.

Who are Andrea Wallen-Gerding's colleagues?

Andrea Wallen-Gerding's colleagues are Chayil Gunpath, Considine Pamela, Cara Davis, Josephine Granna, Lola Arencón Merchan, Monika Schnetz, Melissa Wittenmyer.

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