Cynthia A Busch

Cynthia A Busch Email and Phone Number

Regulatory Affairs Manager, Immunoassays, at Abbott @ Abbott
illinois, united states
Cynthia A Busch's Location
Greater Chicago Area, United States
Cynthia A Busch's Contact Details

Cynthia A Busch work email

Cynthia A Busch personal email

n/a
About Cynthia A Busch

Accomplished Regulatory Affairs Professional with 27 years of experience in healthcare industries. Exemplifies servant leadership to execute and manage technical and scientific regulatory activities.

Cynthia A Busch's Current Company Details
Abbott

Abbott

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Regulatory Affairs Manager, Immunoassays, at Abbott
illinois, united states
Website:
abbott.com
Employees:
82486
Cynthia A Busch Work Experience Details
  • Abbott
    Regulatory Affairs Manager
    Abbott Jan 2021 - Present
    Abbott Park, Usa
    • Develops new regulatory policies; processes and SOPs and train key personnel on them• Evaluates regulatory risks of division policies; processes; procedures• Provides subject matter expertise on regulatory impact of Immunoassay/Clinical Chemistry systems software updates.• Fosters cross functional collaborations with Core Diagnostics business units and Abbott Divisions to develop process improvements for software evaluation and content in 510(k) & PMA submissions.• Performs Regulatory Assessments, Emerging Issues, CAPA/Nonconformance, and Audit support. • Prepares, reviews and submits regulatory submissions to authorities• Negotiates and interacts with regulatory authorities during the development and review process to ensure submission approval.
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  • Siemens Medical Solutions Usa, Inc.
    Regulatory Affairs Specialist
    Siemens Medical Solutions Usa, Inc. Jan 2013 - Dec 2020
    Greater Chicago Area
    • Successfully obtained the division’s first MDR certifications serving as Molecular Imaging Division Project Lead for EU Medical Device Regulations 2017/745 (MDR) Implementation Program.• Authored regulatory operating procedures and guidances and templates at the divisional and corporate level • Performed the writing and filing of 510(k)s, EU CE Mark, China, Japan, Korea, & Canada submission documents• Liaised with global regulatory contacts to maintain current listing of requirements for submissions• Reviewed promotional material and labeling for compliance to US and worldwide regulations• Advised regulatory strategy as key member in Project Steering Committees for new and updated SPECT products• Selected by Siemens Headquarters, Erlangen, Germany as U.S Trainer for EU Clinical Evaluations – only two non-German persons are accredited to teach Headquarters coursework
  • See Project Description Below
    See Project Description Category
    See Project Description Below Apr 2007 - Dec 2010
  • Abbott Laboratories - Global Pharmaceutical Regulatory Division
    Senior Regulatory Affairs Associate
    Abbott Laboratories - Global Pharmaceutical Regulatory Division 2005 - 2007
    Abbott Park, Illinois
    Supported global project teams to ensure worldwide regulatory approval and marketing authorization & manufacturing compliance.Served as U.S. Team Lead for TRACTS: Abbott's custom version of Liquent's InSight Manager for Regulatory registrations.Conducted training with global regulatory user groups to ensure proper registration tracking procedures.Authored and updated policies and procedures for use of U.S & European registration tracking applications.
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  • Abbott Laboratories - Diagnostics Division
    Senior Quality Assurance Professional
    Abbott Laboratories - Diagnostics Division 2002 - 2004
    Abbott Park Illinois
    Subject matter expert for Abbott's implementation of FDA regulation 21 CFR Part 11.Performed 21 CFR Part 11 gap analysis, compliance assessment, and remediation plans on over 100 software systems.Identified compliance gaps and solutions for software design and document control for division-wide systems; Labeling, Medical Events Reporting, Document Management and Training. Conducted training to meet client needs/changes in the regulatory environment
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  • Abbott Laboratories - Diagnostics Division
    Senior Software Validation Engineer - Architect Immunoassay Systems
    Abbott Laboratories - Diagnostics Division 2000 - 2002
    Abbott Park, Illinois
    Conducted functional testing on 'Architect' Chemistry and Immunoassay Analyzer Systems.Created software requirements and validation test plans for verification of instrument function pre-market launch.Tracked discrepancies, applied Criticality Analyses (FMECA) and resolutions for medical device compliance.
  • Tap Holdings (Takeda-Abbott) Via Stopka Consulting
    Clinical Software Quality Assurance Analyst
    Tap Holdings (Takeda-Abbott) Via Stopka Consulting 1999 - 2000
    Bannockburn, Illinois
    Validation planning for Clinical Trials software in Regulatory Affairs.Ensured compliance of regulatory procedures for validation of electronic repositories for Investigational Drug Tracking System and Clinical Trials Case Report Forms & Publications in a Documentum platform.Authored department procedures and user guides for electronic submissions to FDA.
  • Abbott Laboratories - Diagnostics Division
    Software Validation Engineer - Architect Systems; Diagnostic Division
    Abbott Laboratories - Diagnostics Division 1998 - 1999
    Abbott Park, Illinois Via Butler International Consulting
    Validation procedures and database management compliant with FDA and GMP standards.Wrote test cases for prototype analyzer software and hardware.
  • East Carolina University Systems
    Medical Technologist - Transfusion Services
    East Carolina University Systems 1997 - 1998
    Greenville, North Carolina Area
    Performed complex antibody detection, antigen phenotyping and electronic compatibility crossmatch for patient surgical and treatment needs.
  • Craven Regional Medical Center
    Medical Technologist - Supervisor Third Shift
    Craven Regional Medical Center 1995 - 1997
    New Bern, North Carolina
    Coordinated & facilitated laboratory functions of chemistry,microbiology,blood bank, hematology, and phlebotomy departments including routine and stat testing.Documentation of quality control reports.Troubleshooting instrument malfunctionSupervised workload and performance of six department employees.
  • Craven Regional Medical Center
    Medical Technologist - General Rotation
    Craven Regional Medical Center 1994 - 1995
    New Bern, North Carolina
    Performed routine and stat testing for laboratory departments of chemistry, hematology, microbiology, and blood bank.Developed and edited department laboratory test procedures.
  • Duke University Medical Center
    Medical Technologist - Chemistry/Toxicology
    Duke University Medical Center 1993 - 1994
    Durham, North Carolina
    Performed routine and stat testing for therapeutic drug monitoring and toxicology.
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  • Burroughs-Wellcome Company Via Kelly Temporary Services
    Clinical Trials Research Data Administrator
    Burroughs-Wellcome Company Via Kelly Temporary Services 1990 - 1991
    Research Triangle Park, North Carolina
    Performed investigative troubleshooting of data discrepancies & quality assurance monitoring for Case Report Forms in Clinical Studies Phase III trials for AZT.Liaison between Clinical Research Associates, Clincal Data Coordinators, Software Developers and Data Management.

Cynthia A Busch Skills

Fda Validation Cross Functional Team Leadership Medical Devices Gmp Quality Control 21 Cfr Part 11 Healthcare Project Planning Document Management Glp Exposure To Relationships With Regulatory Authorities Regulatory Liaison To It And Product Teams Proficiency Working With Global Regulatory Databases Document Management Of Ectd Marketing Authorizations And Fda Submissions Clinical Trials Data Review Excellent Analytical Problem Solving Skills Excels In Projects Within A Team Environment Passion For Working Under Strict Deadlines

Cynthia A Busch Education Details

Frequently Asked Questions about Cynthia A Busch

What company does Cynthia A Busch work for?

Cynthia A Busch works for Abbott

What is Cynthia A Busch's role at the current company?

Cynthia A Busch's current role is Regulatory Affairs Manager, Immunoassays, at Abbott.

What is Cynthia A Busch's email address?

Cynthia A Busch's email address is bu****@****att.net

What schools did Cynthia A Busch attend?

Cynthia A Busch attended Northeastern University, Duke University Medical Center, North Carolina State University.

What skills is Cynthia A Busch known for?

Cynthia A Busch has skills like Fda, Validation, Cross Functional Team Leadership, Medical Devices, Gmp, Quality Control, 21 Cfr Part 11, Healthcare, Project Planning, Document Management, Glp, Exposure To Relationships With Regulatory Authorities.

Who are Cynthia A Busch's colleagues?

Cynthia A Busch's colleagues are Therese Whaley, Rahul Paul, Shravan Soori, Ana Giron, Karen Britt, Munna Shahriar, Thắng Nguyễn.

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