Wilk Von Gustedt, Ph.D
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Wilk Von Gustedt, Ph.D Email & Phone Number

Director Regulatory Affairs and Quality Assurance at CareDx, Inc.
Location: Belmont, California, United States 8 work roles 1 school
1 work email found @caredx.com LinkedIn matched
✓ Verified May 2026 4 data sources Profile completeness 100%

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Current company
CareDx, Inc.
Role
Director Regulatory Affairs and Quality Assurance
Location
Belmont, California, United States
Company size
736 employees

Who is Wilk Von Gustedt, Ph.D? Overview

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Wilk Von Gustedt, Ph.D is listed as Director Regulatory Affairs and Quality Assurance at CareDx, Inc., a company with 736 employees, based in Belmont, California, United States. AeroLeads shows a work email signal at caredx.com and a matched LinkedIn profile for Wilk Von Gustedt, Ph.D.

Wilk Von Gustedt, Ph.D previously worked as Director Regulatory Affairs/Quality Assurance at Caredx, Inc. and Senior Regulatory Affairs Specialist at Roche Molecular Systems. Wilk Von Gustedt, Ph.D holds Ph.D, Biology from Technical University Of Munich.

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*@caredx.com
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Profile bio

About Wilk Von Gustedt, Ph.D

Quality and Regulatory Affairs professional with strong scientific background and management experience in the Molecular Diagnostics arena. My field of expertise is supporting new product development, US and international submissions, and performing compliance assessments. My accomplishments have been to successfully implement and maintain Quality systems, develop Regulatory strategies and bringing various IVD systems and assays to the market. Specialties: • Regulatory Affairs (FDA class I, II, III and CE-IVD labeled devices) • Regulatory Compliance (21CFR part 820, ISO13485, CMDR, J-GMP, IVDD, MDD, CLIA, CAP) • Project Management• Product and Process Development • Consumables and Instrument Manufacturing and Validations • Quality Systems Implementation • IT Systems and Software Validation

Listed skills include Fda, Validation, Iso 13485, Medical Devices, and 24 others.

Current workplace

Wilk Von Gustedt, Ph.D's current company

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CareDx, Inc.
Caredx, Inc.
Director Regulatory Affairs and Quality Assurance
Belmont, CA, US
Website
caredx.com
Employees
736
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8 roles · 26 years

Wilk Von Gustedt, Ph.D work experience

A career timeline built from the work history available for this profile.

Director Regulatory Affairs And Quality Assurance

Caredx, Inc.

Belmont, CA, US

Director Regulatory Affairs/Quality Assurance

Current
Caredx, Inc.

Brisbane, California, US

Responsible for 21CFR part 820 compliant Quality system in a CLIA/CAP environment➢ Design and Development support for AlloSure a dd-cf-DNA LDT ➢ Created Technical file and registered AlloMap software for CE-IVD labelling➢ Update of all labelling information for AlloMap, re-registration for EU launch with collaborator ➢ Update and revalidation of EDMS.

Jan 2015 - Present

Senior Regulatory Affairs Specialist

Roche Molecular Systems

Switzerland 🇨🇭, CH

Responsible for FDA submissions for Microbiology/Virology and Manufacturing➢ Submission and 510(k) clearance for the following IVD assays: cobas CT/NG v2.0 Test, cobas MRSA, cobas Cdiff and cobas 4800 Software release 2.1.➢ Prepared dossiers for international registrations, launched three Microbiology IVD assays in the EU (cobas HSV1and 2, cobas Cdiff.

Nov 2011 - Dec 2014

Sr. Quality Assurance And Regulatory Affairs Manager

Life Technologies

Waltham, MA, US

  • Responsible for IVD product introduction and leading a group of four direct and six total reports for global compliance and IT systems validation
  • Project lead for the first US/EU -IVD labeled end-point PCR instrument for Life technologies
  • Developed product requirements, design validation, firmware testing, manufacturing process validations, IQ/OQ documentation to support regulatory compliance of IVD device
  • Developed, reviewed and implemented multiple global regulatory and quality policies and procedures to better define LT global Quality system.
  • Implemented global corporate assessment program enabling effective evaluation of sites to QSR and ISO13485.
  • Effectively managed global compliance with no FDA warning letters or 483’s.
2009 - 2011 ~2 yrs

Sr. Quality Assurance Manager

Applied Biosystems Now Life Technologies
  • Responsible for five direct and twenty-two total reports to manage all Quality system requirements for development, manufacturing, distribution at Foster City, Pleasanton, Hayward facilities
  • Provided QA/RA support for development of first diagnostic sequencer
  • Supported 510K submission for 7500Dx (RT-PCR cycler)
  • Key contributor for regulatory infrastructure transformation of the quality system needed to support CE-IVD device manufacturing.
  • Established new metrics and processes for QA, Development and Manufacturing to drive continuous improvement and transform sites to become a "center of excellence".
  • Partnered with Manufacturing to improve CofA, batch record, calibration and validation processes.
2007 - 2009 ~2 yrs

Sr. Quality Assurance Manager

Affymetrix

Santa Clara, California, US

  • Responsible for implementation and maintenance of Site Quality Systems
  • Performed process improvements in collaboration with R&D and Manufacturing
2006 - 2007 ~1 yr

Lead Auditor And Account Manager

Tuv America

Munich, Germany, DE

  • Responsible for auditing of Diagnostic and Medical device companies for compliance to Regulatory and Quality System related standards
  • Managed collaborations and alliances with TUV America customers and accredited over 80 diagnostic and medical device companies to multiple regulatory standards and requirements. (ISO 13485:2003, the Canadian Medical.
2003 - 2006 ~3 yrs

Key Account And Customer Support Manager

Biomax Informatics Ag

Planegg, Bavaria, DE

Responsible for Sales and Consulting of Bioinformatics Software Tools in Germany, Europe and US

2000 - 2003 ~3 yrs
Team & coworkers

Colleagues at CareDx, Inc.

Other employees you can reach at caredx.com. View company contacts for 736 employees →

TV Thierry Viard Thierry Viard Colleague at Caredx, Inc. San Francisco Bay Area, United States, United States View → JY Jesica Yau Jesica Yau Colleague at Caredx, Inc. United States, United States View → SC Steve Chang Steve Chang Colleague at Caredx, Inc. Englewood, Colorado, United States, United States View → KK Keith Kennedy Keith Kennedy Colleague at Caredx, Inc. San Francisco Bay Area, United States, United States View → ST Stephanie Thompson Stephanie Thompson Colleague at Caredx, Inc. United States, United States View → ML Marta(Mercy) Lopez Marta(Mercy) Lopez Colleague at Caredx, Inc. San Bruno, California, United States, United States View → JB Jonathan Banzon Jonathan Banzon Colleague at Caredx, Inc. Dublin, California, United States, United States View → JA Jessica Abad Jessica Abad Colleague at Caredx, Inc. Sunnyvale, California, United States, United States View → JT Jason Tabor, Mba Jason Tabor, Mba Colleague at Caredx, Inc. Berlin, Massachusetts, United States, United States View → BC Brandie Casassa Brandie Casassa Colleague at Caredx, Inc. Worcester, Massachusetts, United States, United States View →
1 education record

Wilk Von Gustedt, Ph.D education

  • Technical University Of Munich
    Technical University Of Munich
    Biology
FAQ

Frequently asked questions about Wilk Von Gustedt, Ph.D

Quick answers generated from the profile data available on this page.

What company does Wilk Von Gustedt, Ph.D work for?

Wilk Von Gustedt, Ph.D works for CareDx, Inc..

What is Wilk Von Gustedt, Ph.D's role at CareDx, Inc.?

Wilk Von Gustedt, Ph.D is listed as Director Regulatory Affairs and Quality Assurance at CareDx, Inc..

What is Wilk Von Gustedt, Ph.D's email address?

AeroLeads has found 1 work email signal at @caredx.com for Wilk Von Gustedt, Ph.D at CareDx, Inc..

Where is Wilk Von Gustedt, Ph.D based?

Wilk Von Gustedt, Ph.D is based in Belmont, California, United States while working with CareDx, Inc..

What companies has Wilk Von Gustedt, Ph.D worked for?

Wilk Von Gustedt, Ph.D has worked for Caredx, Inc., Roche Molecular Systems, Life Technologies, Applied Biosystems Now Life Technologies, and Affymetrix.

Who are Wilk Von Gustedt, Ph.D's colleagues at CareDx, Inc.?

Wilk Von Gustedt, Ph.D's colleagues at CareDx, Inc. include Thierry Viard, Jesica Yau, Steve Chang, Keith Kennedy, and Stephanie Thompson.

How can I contact Wilk Von Gustedt, Ph.D?

You can use AeroLeads to view verified contact signals for Wilk Von Gustedt, Ph.D at CareDx, Inc., including work email, phone, and LinkedIn data when available.

What schools did Wilk Von Gustedt, Ph.D attend?

Wilk Von Gustedt, Ph.D holds Ph.D, Biology from Technical University Of Munich.

What skills is Wilk Von Gustedt, Ph.D known for?

Wilk Von Gustedt, Ph.D is listed with skills including Fda, Validation, Iso 13485, Medical Devices, Quality System, V&V, Biotechnology, and Regulatory Affairs.

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