President
Current
Expert Medical Device Consulting, Inc.
Apr 2012 - Present
AeroLeads people directory · profile
Steve White Email & Phone Number
Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax
at
Expert Medical Device Consulting, Inc.
1 phone found
area 561
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Expert Medical Device Consulting, Inc.
Role
Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax
Location
West Palm Beach, Florida, United States
Who is Steve White? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Steve White is listed as Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax at Expert Medical Device Consulting, Inc., based in West Palm Beach, Florida, United States. AeroLeads shows phone signal with area code 561 and a matched LinkedIn profile for Steve White.
Steve White previously worked as President at Expert Medical Device Consulting, Inc. and Principal Consultant at Expert Medical Device Consulting, Inc.. Steve White holds Bs Che, Chemical Engineering from Auburn University.
Profile bio
About Steve White
Medical Device/Combination Product Consultant designing and implementing Globally compliant Design Controls, Risk Management and Quality Management Systems. Collaborative approach and hands on expertise in working with international teams.Aided many clients in successful resolution of 483 warning letters, consent decrees, and remediation & corrections to Design Controls, Design History Files, Risk Management Files, Usability Engineering File and Technical Files.Specialties: >EU MDR STeD File conversion and conformance to EU MDR 745/746>Quality Systems and Regulatory Compliance: 483 and Consent Decree response programs>Design Controls, Risk Management implementation and integration across all QMS. >Program Management; R&D, NPD, QSR and EU MDR Remediation Planning and Implementation>Team Leadership; Cross-functional Dynamics and Mentoring>Regulatory Compliance; ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 210/211, 21 CFR Part 4, EU MDR 2017/745, various IEC/ASTM industry standards
Listed skills include Quality Systems, R&D, Product Development, Capa, and 46 others.
Current workplace
Steve White's current company
Company context helps verify the profile and gives searchers a useful next step.
Expert Medical Device Consulting, Inc.
10 roles · 25 years
Steve White work experience
A career timeline built from the work history available for this profile.
Principal Consultant
Expert Medical Device Consulting, Inc.
Led the Risk Management File Review and Assessment for on-market Combination Products. Reported gaps in compliance to ISO 14971 and made recommendations for QMS improvements and remediation of Risk File documents.
Oct 2021 - May 2022
Risk Files And Qms Assessment Lead
Oct 2021 - Dec 2021
Sme Ddqe For Dhf Remediation
Jun 2020 - Dec 2021
Eu Mdr Sted Lead
Validant Consulting
Jun 2018 - Jun 2020
Subject Matter Expert
Aided Company in meeting challenging Regulatory and Quality System Goals as Subject Matter Expert. Provided SME leadership to Process/Risk Management remediation teams and supported Test Method Validations.
Jun 2014 - Feb 2015
Subject Matter Expert And Lead For Design Transfer
Hospira
Providing SME expertise and co-leadership to internal team to remediate gaps and develop procedures to implement best practices for Design Transfer, Process Validation, Test Method Validation and Service Processes to meet global regulatory compliance.
Feb 2013 - May 2014
Sme-Design Controls And Product Realization Consultant
Developing and implementing quality systems and best practices for product realization and design controls in the division's product development and service organizations.
Jan 2011 - Jan 2013
Director Advanced Product Development
Developed Quality Management Systems, Agile PLM and Surgical Systems for LVAD implants
Jul 2006 - Aug 2009
Director New Product Development
Biomet 3I
Implemented Design Controls and Risk Management Quality systems. Led the Product Development organization for innovative dental implant and restoration product(s) implementation.
2001 - 2005
~4 yrs
4 education records
Steve White education
Bs Che, Chemical Engineering
Auburn University
Mba, International Business
The University Of Dallas
Master Of Business Administration - Mba, International Business
The University Of Dallas
Master Of Business Administration - Mba, International Business
The University Of Dallas
FAQ
Frequently asked questions about Steve White
Quick answers generated from the profile data available on this page.
What company does Steve White work for?
Steve White works for Expert Medical Device Consulting, Inc..
What is Steve White's role at Expert Medical Device Consulting, Inc.?
Steve White is listed as Lead Consultant for Design Control, Design History File and Risk Management Implementation for Combination Product @ Novavax at Expert Medical Device Consulting, Inc..
What is Steve White's phone number?
AeroLeads has found 1 phone signal(s) with area code 561 for Steve White at Expert Medical Device Consulting, Inc..
Where is Steve White based?
Steve White is based in West Palm Beach, Florida, United States while working with Expert Medical Device Consulting, Inc..
What companies has Steve White worked for?
Steve White has worked for Expert Medical Device Consulting, Inc., Amgen, Pfizer, Validant Consulting, and Terumo Cardiovascular Systems.
How can I contact Steve White?
You can use AeroLeads to view verified contact signals for Steve White at Expert Medical Device Consulting, Inc., including work email, phone, and LinkedIn data when available.
What schools did Steve White attend?
Steve White holds Bs Che, Chemical Engineering from Auburn University.
What skills is Steve White known for?
Steve White is listed with skills including Quality Systems, R&D, Product Development, Capa, Iso 13485, Iso 14971, Cgmp Practices, and Iec 60601.
Find 750M verified contacts
Search by job title, company, industry, location, and seniority. Export verified B2B contact data when you need it.
Start free trial