Manager, Regulatory Affairs
Current
Nov 2021 - Present
AeroLeads people directory · profile
Carolyn Schmitt Rac (Us) (She/Her) Email & Phone Number
Manager, Regulatory Affairs
at
PTS Diagnostics
1 work email found
@ptsdiagnostics.com
LinkedIn matched
✓ Verified Jun 2026
4 data sources
Profile completeness 100%
Current company
Role
Manager, Regulatory Affairs
Location
Fishers, Indiana, United States
Company size
Who is Carolyn Schmitt Rac (Us) (She/Her)? Overview
A concise factual answer block for searchers comparing this professional profile.
Quick answer
Carolyn Schmitt Rac (Us) (She/Her) is listed as Manager, Regulatory Affairs at PTS Diagnostics, a company with 143 employees, based in Fishers, Indiana, United States. AeroLeads shows a work email signal at ptsdiagnostics.com and a matched LinkedIn profile for Carolyn Schmitt Rac (Us) (She/Her).
Carolyn Schmitt Rac (Us) (She/Her) previously worked as Regulatory Affairs Specialist II at Pts Diagnostics and Regulatory Compliance Analyst at Roche. Carolyn Schmitt Rac (Us) (She/Her) holds Masters Of Science, Regulatory Affairs For Drugs, Biologics And Medical Devices from Northeastern University.
Company email context
Email format at PTS Diagnostics
This section adds company-level context without repeating Carolyn Schmitt Rac (Us) (She/Her)'s masked contact details.
*@ptsdiagnostics.com
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AeroLeads found 1 current-domain work email signal for Carolyn Schmitt Rac (Us) (She/Her). Compare company email patterns before reaching out.
Profile bio
About Carolyn Schmitt Rac (Us) (She/Her)
Service-oriented quality professional with over fifteen years experience working in FDA regulated industries. Strong project management and document auditing skills with proven technical capabilities. Experienced in partnering with multiple functional areas to meet overall business objectives
Listed skills include Fda, Quality System, Medical Devices, Capa, and 24 others.
Current workplace
Carolyn Schmitt Rac (Us) (She/Her)'s current company
Company context helps verify the profile and gives searchers a useful next step.
Pts Diagnostics
9 roles
Carolyn Schmitt Rac (Us) (She/Her) work experience
A career timeline built from the work history available for this profile.
Regulatory Affairs Specialist Ii
Feb 2020 - Nov 2021
Regulatory Compliance Analyst
Review and process customer complaints for the Professional Diagnostics product lines. Escalate cases for resolution and report cases to the Food and Drug Administration as needed.
Jan 2011 - Feb 2020
Aspire Program Graduate
Aspire was a group mentoring development program for individual contributors who demonstrate high potential and desire to explore leadership at Roche.
Oct 2012 - Nov 2013
Quality Systems Engineer
Audit quality control laboratory data for all product lines in the Centralized Diagnostics division at all stages of the manufacturing process in accordance with regulatory guidelines. Coordinator of the real time stability program for Centralized Diagnostics.
Jan 2008 - Dec 2010
Scientist
Performed quality testing on over 300 raw materials and bulk products at all stages in the manufacturing process. Administered the Farm Management Project, which provides critical raw materials for the production of select drugs of abuse testing products.
Oct 2004 - Dec 2007
Microbiologist
Jul 2003 - Oct 2004
Staff Cytotechnologist
Pathologists Associated
Feb 2001 - May 2003
Staff Cytotechnologist
Diagnostic Cytology Laboratory
Aug 1999 - Feb 2001
Team & coworkers
Colleagues at PTS Diagnostics
Other employees you can reach at ptsdiagnostics.com. View company contacts for 143 employees →
PG
Prapoorna Garimella
Colleague at Pts DiagnosticsUnited States, United States
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TM
Tony Meineke
Colleague at Pts DiagnosticsGreater Indianapolis, United States
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FS
Fakhri Syazz
Colleague at Pts DiagnosticsButterworth, Penang, Malaysia, Malaysia
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JC
Jenjenn C.
Colleague at Pts DiagnosticsSan Francisco Bay Area, United States
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KM
Karmen Mercer
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
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MK
Michael Kraus
Colleague at Pts DiagnosticsBranford, Connecticut, United States, United States
View →
AR
April Robinson
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
View →
YK
Younis Khan Khoso
Colleague at Pts DiagnosticsPir Jo Goth, Sindh, Pakistan, Pakistan
View →
SS
Sushil Shinde
Colleague at Pts DiagnosticsMumbai, Maharashtra, India, India
View →
CB
Claudia Bautista
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
View →
Prapoorna Garimella
Colleague at Pts DiagnosticsUnited States, United States
View →
TM
Tony Meineke
Colleague at Pts DiagnosticsGreater Indianapolis, United States
View →
FS
Fakhri Syazz
Colleague at Pts DiagnosticsButterworth, Penang, Malaysia, Malaysia
View →
JC
Jenjenn C.
Colleague at Pts DiagnosticsSan Francisco Bay Area, United States
View →
KM
Karmen Mercer
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
View →
MK
Michael Kraus
Colleague at Pts DiagnosticsBranford, Connecticut, United States, United States
View →
AR
April Robinson
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
View →
YK
Younis Khan Khoso
Colleague at Pts DiagnosticsPir Jo Goth, Sindh, Pakistan, Pakistan
View →
SS
Sushil Shinde
Colleague at Pts DiagnosticsMumbai, Maharashtra, India, India
View →
CB
Claudia Bautista
Colleague at Pts DiagnosticsIndianapolis, Indiana, United States, United States
View →
2 education records
Carolyn Schmitt Rac (Us) (She/Her) education
Masters Of Science, Regulatory Affairs For Drugs, Biologics And Medical Devices
Bs, Clinical Laboratory Science, Cytotechnology
FAQ
Frequently asked questions about Carolyn Schmitt Rac (Us) (She/Her)
Quick answers generated from the profile data available on this page.
What company does Carolyn Schmitt Rac (Us) (She/Her) work for?
Carolyn Schmitt Rac (Us) (She/Her) works for PTS Diagnostics.
What is Carolyn Schmitt Rac (Us) (She/Her)'s role at PTS Diagnostics?
Carolyn Schmitt Rac (Us) (She/Her) is listed as Manager, Regulatory Affairs at PTS Diagnostics.
What is Carolyn Schmitt Rac (Us) (She/Her)'s email address?
AeroLeads has found 1 work email signal at @ptsdiagnostics.com for Carolyn Schmitt Rac (Us) (She/Her) at PTS Diagnostics.
Where is Carolyn Schmitt Rac (Us) (She/Her) based?
Carolyn Schmitt Rac (Us) (She/Her) is based in Fishers, Indiana, United States while working with PTS Diagnostics.
What companies has Carolyn Schmitt Rac (Us) (She/Her) worked for?
Carolyn Schmitt Rac (Us) (She/Her) has worked for Pts Diagnostics, Roche, Roche Diagnostics, Eli Lilly And Company, and Pathologists Associated.
Who are Carolyn Schmitt Rac (Us) (She/Her)'s colleagues at PTS Diagnostics?
Carolyn Schmitt Rac (Us) (She/Her)'s colleagues at PTS Diagnostics include Prapoorna Garimella, Tony Meineke, Fakhri Syazz, Jenjenn C., and Karmen Mercer.
How can I contact Carolyn Schmitt Rac (Us) (She/Her)?
You can use AeroLeads to view verified contact signals for Carolyn Schmitt Rac (Us) (She/Her) at PTS Diagnostics, including work email, phone, and LinkedIn data when available.
What schools did Carolyn Schmitt Rac (Us) (She/Her) attend?
Carolyn Schmitt Rac (Us) (She/Her) holds Masters Of Science, Regulatory Affairs For Drugs, Biologics And Medical Devices from Northeastern University.
What skills is Carolyn Schmitt Rac (Us) (She/Her) known for?
Carolyn Schmitt Rac (Us) (She/Her) is listed with skills including Fda, Quality System, Medical Devices, Capa, Gmp, Validation, Biotechnology, and Quality Control.
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