Darlene Garner

Regulatory Affairs Manager

Darlene Garner has been working as a Regulatory Affairs Manager in Syntactx since 2018. Moreover, Darlene has an employment history at more than eight companies in the relevant field. Darlene has a total work experience of 38+ years. Darlene Garner studied at the University of Houston - Clear Lake from 1999 to 2003. Nowadays the person lives in Houston, Texas region. You can find Darlene Garner's actual contacts through our search.
Name variants:
Darleen Garner, Darlyne Garner, Lena Garner, Darla Garner
Last updated May 04, 2024

Contact Information

Last Update
Jul 11, 2022
Email
dg**@syntactx.com, da**@embarqmail.com, dg**@idevmd.com
Location
Houston, TX
Company

Workplace

Syntactx
Regulatory Affairs Manager

New York, NY

Industry

Medical Devices, Nonclassifiable Establishments, Noncommercial Research Organization

Work History

Regulatory Affairs Manager

150 Greenwich St, New York, NY 10006
from May 2018

Senior Regulatory Affairs Specialist

Aug 2014 — Apr 2018

Director Regulatory Affairs

253 Medical Center Blvd, Webster, TX 77598
Feb 2011 — Mar 2014

Regulatory Affairs Manager

253 Medical Center Blvd, Webster, TX 77598
Sep 2007 — 2011

Regulatory Affairs Specialist

253 Medical Center Blvd, Webster, TX 77598
Sep 2007 — Jun 2010

Senior Manager, Medical Device Reporting

Mar 2001 — Apr 2006

Regulatory Affairs Specialist

Apr 2000 — Mar 2001

Regulatory Affairs Specialist

The majority of my time at Intermedics was spent managing Medical Device Reporting and Conducting Quality System audits. Additionally, I assisted in preparing product submissions.
Mar 1981 — Aug 1999

Occupations

Executive
Manager
Operations Manager

Skills

Regulatory Affairs
Medical Devices
Fda
Iso 13485
Design Control
Capa
Quality System
Validation
V&V
Iso 14971
Clinical Trials
Gmp
Regulatory Submissions
Gcp
Pma
R&D
Biomedical Engineering
Sop
Ce Marking
Cardiology
Commercialization
21 Cfr
Regulatory Requirements
U.s. Food and Drug Administration
Verification and Validation
Iso
Design of Experiments
Premarket Approval
Iso Standards
Corrective and Preventive Action
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