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Profile Details
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USD 250 /hr
Hire Kristen D.
United States
USD 250 /hr

Seasoned Global Clinical Operations & Regulatory Affairs Medical Devices Specialist

Profile Summary
Subject Matter Expertise
Services
Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Creative Writing, Audio Transcription, General Proofreading & Editing
Research User Research, Feasibility Study, Technology Scouting, Fact Checking, Gap Analysis, Gray Literature Search, Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection
Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting
Data & AI Data Mining, Data Cleaning, Data Processing
Product Development Material Sourcing, Product Compliance , Concept Development, Product Launch Support
Work Experience

Executive Advisor

A&C Foundation

May 2025 - Present

Executive Advisor

A+C Foundation

May 2025 - Present

VP Clinical & Regulatory

Newronika S.p.A.

April 2023 - October 2024

VP Clinical & Regulatory

Newronika S.p.A.

April 2023 - October 2024

Senior Clinical Director

Functional Neuromodulation

May 2019 - December 2023

Senior Clinical Director

Functional Neuromodulation

May 2019 - December 2023

Global Manager

Syneos Health (United States)

October 2016 - April 2019

Global Manager - Clinical Operations

Syneos Health (Previously INCResearch)

October 2016 - April 2019

Senior Clinical Manager

Functional Neuromodulation

March 2012 - October 2016

Senior Clinical Manager

Functional Neuromodulation

January 2012 - October 2016

Research Quality Improvement Specialist

Baylor University Medical Center

January 2011 - March 2012

Research Quality Improvement Specialist

Baylor University Medicall Center - Baylor Research Institute

January 2011 - March 2012

Global Regulatory Affairs Manager

Flextronics - Avail Medical Division

August 2008 - January 2011

Corporate Global Regulatory Affairs Manager

Flextronics International

August 2008 - January 2011

Director of Clinical & Regulatory Affairs

Organ Transport Systems

June 2006 - July 2008

Director - Clinical & Regulatory Affairs

Organ Transport Systems

June 2006 - July 2008

Clinical Program Manager

Advanced Neuromodulation Systems

April 2004 - May 2006

Clinical Program Manager - Deep Brain Stimulation

Advanced Neuromodulation Systems

April 2004 - May 2006

Senior Clinical Research Associate

Johnson & Johnson

February 2003 - April 2004

Senior Clinical Research Associate

Crocath Technologies

January 2001 - February 2003

Senior Clinical Research Associate

CryoCath Technologies

January 2001 - February 2003

Global Clinical Manager

BioInterventional

August 1999 - January 2001

Senior Clinical Specialist & Trainer

St. Jude Medical

September 1997 - August 1999

Senior Staff Physiologist

Cleveland Clinic

July 1993 - September 1997

Education

Masters (Science)

Central Michigan University

August 1991 - May 1997

Graduate Internship

University of Michigan

January 1993 - July 1993

Physiology (Health Education & Sciences )

Central Michigan University

1991 - 1993

Bachelor of Science (Psychology)

Michigan State University

September 1986 - June 1990

Bachelor of Science

Michigan State University

September 1986 - June 1990

Certifications
Publications
JOURNAL ARTICLE
Jurgen Germann, Amaral RSC, Tomaszczyk J, Yamamoto K, Elias GJB, Gouveia FV, Vasilevskaya A, Taghdiri F, Devenyi GA, Sankar T, et al. (2025). Biomarker changes associated with fornix deep brain stimulation in Alzheimer's disease . Alzheimer's & dementia : the journal of the Alzheimer's Association.
Steven D. Targum, Fosdick L, Drake KE, Rosenberg PB, Burke AD, Wolk DA, Kelly Foote, Wael Asaad, Sabbagh M, Smith GS, et al. (2021). Effect of Age on Clinical Trial Outcome in Participants with Probable Alzheimer's Disease . Journal of Alzheimer's disease : JAD.
Jeannie-Marie Leoutsakos, Yan H, William Anderson, Wael Asaad, Baltuch G, Burke A, Chakravarty MM, Drake KE, Kelly Foote, Fosdick L, et al. (2018). Deep Brain Stimulation Targeting the Fornix for Mild Alzheimer Dementia (the ADvance Trial): A Two Year Follow-up Including Results of Delayed Activation . Journal of Alzheimer's disease : JAD.
Andres M. Lozano, Fosdick L, Chakravarty MM, Jeannie-Marie Leoutsakos, Munro C, Oh E, Drake KE, Lyman CH, Rosenberg PB, William Anderson, et al. (2016). A Phase II Study of Fornix Deep Brain Stimulation in Mild Alzheimer's Disease . Journal of Alzheimer's disease : JAD.