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Eric Kolodziej Email & Phone Number
SVP, Quality, Regulatory, and Clinical Affairs
at
Beckman Coulter Diagnostics
LinkedIn matched
✓ Verified Jun 2026
3 data sources
Profile completeness 86%
Current company
Role
SVP, Quality, Regulatory, and Clinical Affairs
Location
Greater Indianapolis, United States, United States
Who is Eric Kolodziej? Overview
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Quick answer
Eric Kolodziej is listed as SVP, Quality, Regulatory, and Clinical Affairs at Beckman Coulter Diagnostics, based in Greater Indianapolis, United States, United States. AeroLeads shows a matched LinkedIn profile for Eric Kolodziej.
Eric Kolodziej previously worked as Corporate VP, Global Head Quality and Regulatory Affairs at Hologic, Inc. and Global Head, SVP Quality and Regulatory Affairs at Roche Diagnostics. Eric Kolodziej holds Ph.D., Analytical/Medicinal Chemistry from Purdue University.
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Beckman Coulter Diagnostics
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Profile bio
About Eric Kolodziej
Experienced Head of Quality Assurance and Regulatory Affairs with a demonstrated success in leading large teams in the medical device, pharmaceutical, and consumer healthcare industries. Strong leadership and people development skills coupled with professional expertise in GMP, Pharma, Medical Devices, Regulatory Policy and Submissions, Quality Management, Quality Assurance, Supplier Quality, Design Quality Assurance, and Quality Control.Core Competencies:*Global Corporate Quality, Regulatory and Clinical Strategy - Med Devices, Pharma, Consumer Health*Regulatory Compliance/Strategy/Approvals (CE Mark, 510k, PMA, ANDA)*Global Q&RA team management - muti-site and International experience*FDA/EMEA/NMPA/ANVISA interactions and audit management*Global Harmonization and Restructuring *M&A Integration/Diligence*Board Level Engagement*Remediation of 483s, Warning Letters, Product Recalls*Global outsourcing/cost reduction/efficiency and process improvementKey Achievements:*Diligence and integration of six acquisitions over 2 year period*MDR/IVDR remediation on-time and on-budget*Redesigned international registration process that launched over 200 new products globally resulting in growth of $1.5B business*Install Global Supply Chain Quality and Distribution team leading to governance models and improved controls*Implemented new Complaint investigation process that drove complaint reductions of over 25%*Leading AI strategy with FDA for imaging product portfolio*Implemented corporate wide Good Promotional Practices and process for handling off-label inquiries*Delivered more than 20 Class 3 and 15 Class 2 device submissions per year in Diagnostics*Introduced Regulatory Policy function to drive engagement and thought leadership in AI and RWE*Led team that secured first ever companion diagnostic as well as the first HPV Primary Screening test in US*Drove best in class regulatory submission approval/clearance rate and speed for two major medtech companies*Developed diverse team of strategic business partners/leaders at multiple companies that later became senior leaders in major pharma and device companiesKey Interpersonal Skills:*Negotiation/Influencing*Communication*Strong bias to action and accountability*Analytical reasoning and problem-solving*Talent development and mentoring
Current workplace
Eric Kolodziej's current company
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9 roles · 24 years
Eric Kolodziej work experience
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Svp, Quality, Regulatory, And Clinical Affairs
CurrentResponsible for global Quality, Regulatory, and Clinical Affairs at leading Disgnosyics company.
Feb 2024 - Present
Corporate Vp, Global Head Quality And Regulatory Affairs
Responsible for quality, compliance and regulatory affairs activities globally for all Hologic business areas including Diagnostics, Breast/Skeletal Health, Diagnostic Imaging, and Gyn/Surgical Solutions. Responsible for all global site quality operations, supply chain quality, global audit, Quality Systems and design quality assurance. Lead global.
Jun 2019 - Feb 2024
Global Head, Svp Quality And Regulatory Affairs
Roche Diagnostics
Responsible for quality, compliance and regulatory affairs activities globally for all Roche Diagnostics sites. Responsible for all global site quality operations, supply chain quality, global audit, Quality Systems and design quality assurance. Also lead global Regulatory Affairs function with responsibility for regulatory submissions and regulatory.
2013 - 2019
~6 yrs
Senior Vp, Global Regulatory Affairs, Roche Diagnostics
Roche Diagnostics
Lead Global Regulatory Affairs organization responsible for all submission and registration activity; participate on Roche/Genentech companion diagnostic team; lead quality and compliance organization for US based Roche Diagnostics Operations
2010 - 2013
~3 yrs
Vp, Quality And Compliance; Head, Us Regulatory Affairs
Roche Diagnostics
Led US quality and compliance organization for diagnostics company with responsibility for multiple product areas. Provided executive oversight for all quality systems and processes and leadership for more than 300 professionals. Principle contact for regulatory authorities. Led US Regulatory Affairs organization with responsibilities for all 510k and PMA.
2007 - 2010
~3 yrs
Vp, Quality And Compliance
Led global Quality and Compliance organization for world's largest manufacturer of OTC drugs. Responsible for quality assurance, quality control, quality systems and processes at seven sites globally with management responsibility for over 600 scientists and quality professionals. Principle contact to regulatory authorities.
2005 - 2007
~2 yrs
Senior Director, Qa/Ac
Direct and manage all Quality Control and Quality Assurance functions for Michigan operations of OTC pharmaceutical company, including all raw material and finished goods testing, QA inspection and release, internal and supplier auditing, CAPA, Quality Engineering, Deviation investigations, Customer Complaints, and cGMP training. Supervise two directors.
2003 - 2005
~2 yrs
Director Of Quality Control
Direct and manage Quality Control department of OTC pharmaceutical company including analytical chemistry, microbiology, stability, and components/pre-print testing functions at multiple locations.Ensure lab control systems are compliant to cGMP and used in the testing and evaluation of raw materials, packaging components, in-process materials, and samples.
2002 - 2003
~1 yr
2 education records
Eric Kolodziej education
Ph.D., Analytical/Medicinal Chemistry
Purdue University
Bs, Chemistry
Valparaiso University
FAQ
Frequently asked questions about Eric Kolodziej
Quick answers generated from the profile data available on this page.
What company does Eric Kolodziej work for?
Eric Kolodziej works for Beckman Coulter Diagnostics.
What is Eric Kolodziej's role at Beckman Coulter Diagnostics?
Eric Kolodziej is listed as SVP, Quality, Regulatory, and Clinical Affairs at Beckman Coulter Diagnostics.
Where is Eric Kolodziej based?
Eric Kolodziej is based in Greater Indianapolis, United States, United States while working with Beckman Coulter Diagnostics.
What companies has Eric Kolodziej worked for?
Eric Kolodziej has worked for Beckman Coulter Diagnostics, Hologic, Inc., Roche Diagnostics, and Perrigo.
How can I contact Eric Kolodziej?
You can use AeroLeads to view verified contact signals for Eric Kolodziej at Beckman Coulter Diagnostics, including work email, phone, and LinkedIn data when available.
What schools did Eric Kolodziej attend?
Eric Kolodziej holds Ph.D., Analytical/Medicinal Chemistry from Purdue University.
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