Tracy Eberly Email & Phone Number

Regulatory Affairs Consultant @ OrthoCor Medical, Inc.

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Tracy Eberly Location

Minneapolis, MN, US

Tracy Eberly Work

Regulatory Affairs Consultant @ (June 2025 - Present)
Regulatory Affairs Consultant @ OrthoCor Medical, Blaine, MN (January 2025 - Present)
RA and QA Consultant @ Fang Consulting (September 1999 - Present)
Owner @ Fang Consulting (January 1999 - Present)
Chief Executive Officer @ Fang Consulting (November 1999 - December 2024)
Regulatory Affairs Consultant @ Tactile Medical, New Brighton, MN (January 2026 - January 2026)
Regulatory Affairs Consultant @ Biologics Consulting Group, Alexandria, VA (January 2025 - January 2026)
Regulatory Affairs Consultant @ Abbott Vascular (September 2019 - December 2024)
MDR RA Consultant @ (September 2017 - December 2019)
Regulatory Affairs Consultant @ (September 2015 - December 2019)
Quality Assurance Manager @ Manual Surgical Sciences (December 2015 - November 2019)
Regulatory Affairs Consultant @ MedInvent, LLC (November 2013 - June 2019)
Support Consultant @ J&J DePuy Synthes (August 2017 - December 2018)
Quality and Regulatory Consultant @ (May 2014 - December 2017)
Senior Consultant @ (February 2017 - November 2017)
Quality Assurance Manager @ Rhythym Xience (March 2015 - February 2017)
Quality Assurance Manager @ Devicix by Nortech (June 2014 - February 2017)
RA Consultant @ (November 2014 - March 2015)
Regulatory Affairs Consultant @ American Medical Systems (BSC) (March 2014 - October 2014)
RA Consultant @ (March 2014 - September 2014)
Regulatory Affairs Consultant @ Fresenius Medical Corporation (August 2013 - March 2014)
Regulatory Affairs Consultant @ Genii, Inc. (June 2012 - September 2013)
RA-QA Specialist @ Genii, Inc. (May 2012 - September 2013)
Compliance Engineer @ (June 2012 - June 2013)
Contract Approvals Engineer @ (May 2012 - June 2013)
Regulatory Affairs Consultant @ (June 2011 - April 2012)
RA Consultant @ (June 2011 - March 2012)
Regulatory Affairs Consultant @ Vital Images (February 2011 - June 2011)
Regulatory Affairs Consultant @ Johnson & Johnson Animas (November 2010 - January 2011)
Regulatory Affairs Consultant @ Hemostasis (December 2008 - July 2010)
Regulatory Affairs Consultant @ (March 2010 - May 2010)
Consultant @ (March 2008 - March 2010)
Regulatory Affairs Consultant @ (January 2007 - January 2008)
Regulatory Affairs Consultant @ (January 2006 - January 2007)
Regulatory Affairs Consultant @ (September 2005 - June 2006)
Sr. Regulatory Affairs Specialist @ (June 2005 - June 2006)
Regulatory Affairs Consultant @ CVRx (January 2004 - September 2005)
Regulatory Affairs Consultant @ (August 2003 - January 2004)
Staff Compliance Engineer @ (April 2001 - August 2003)
Regulatory Affairs Consultant @ Mallinckrodt Inc. (June 1997 - May 2000)
R and D Engineer @ Microvena Corporation (January 1996 - January 1997)
Project Manager @ Medtronic (formerly Microvena Corporation, EV3, Covidien) (January 1996 - January 1997)
Compliance Engineer @ Boston Scientific (formerly Cardiac Pacemakers, Inc., Guidant) (January 1995 - January 1996)
Test Engineer @ Boston Scientific (formerly American Medical Systems) (January 1994 - January 1995)
Research And Development Technician @ Boston Scientific (formerly SciMed Life Systems) (January 1991 - January 1994)

Tracy Eberly Education

University of Minnesota
BS Multidisciplinary Studies (Mechanical Eng, Communication)
1984-2009
University of Minnesota
Bachelor of Science

Tracy Eberly Skills

21 CFR
510(k)
Annual Reports
Article Submission
Asset Dispositions
Automated External Defibrillator (AED)
Biomedical Sciences
Biotechnology
Businessowners
CAPA
CE marking
CMDCAS
Cardiology
Catheters
Certified Manager of Quality
Cigars
Clinical Affairs
Clinical Reporting
Clinical Trials
Compliance Engineering
Consulting
Cross-functional Team Leadership
Cybersecurity
Design & Access Statements
Design Control
Design Dossier
Design Standards
Design Team Coordination
Development & Production of Publications
Development & implementation of marketing plans
Dossier Preparation
EU MDR
Engineering change request (ECR)
European Union
Evidence-based Design
FDA
Federal & State Regulatory Compliance
GMP
Global Regulatory Compliance
High Performance Teams
Hydroprocessing
IDE
IEC 60601
ISO
ISO 13485
ISO 14971
IVDR
Import Compliance
Insulin Pumps
Insurance Authorizations
Internal Audits
International Regulations
Logo Design
Marketing Agreements
Medical Devices
Orthopedic
Orthopedics
PMA
Pre-commissioning
Product Development
Product Launch
Product Strategy
Project Reporting
Quality Assurance
Quality Auditing
Quality System
R&D
Regulatory Affairs
Regulatory Approvals
Regulatory Examinations
Regulatory Labeling
Regulatory Requirements
Regulatory Standards
Regulatory Strategy Development
Regulatory Submissions
Research and Development (R&D)
Risk Management
Ship Design
Software Updates
Submittals
Supplier Audits
Systematic Reviews
Technical Documentation
Technical Files
Technical Standards
Technologists
Third Party Reporting
Tissue Banking
U.S. Food and Drug Administration (FDA)
Validation

Tracy Eberly Summary

Tracy Eberly, based in Minneapolis, MN, US, is currently a Regulatory Affairs Consultant at OrthoCor Medical, Inc.. Tracy Eberly brings experience from previous roles at OrthoCor Medical, Blaine, MN and Fang Consulting. Tracy Eberly holds a 1984 - 2009 BS Multidisciplinary Studies in Mechanical Eng, Communication @ University of Minnesota. With a robust skill set that includes 21 CFR, 510(k), Annual Reports, Article Submission, Asset Dispositions and more. Tracy Eberly has 2 emails and 2 mobile phone numbers on RocketReach.