Global Head Of Regulatory Affairs
Current
May 2024 - Present
AeroLeads people directory · profile
Michaela Hoffmeyer Email & Phone Number
Regulatory Affairs Executive | IVD Expert | PoC CLIA Waiver | OTC | Clinical Affairs | ISO 13485 | ISO 20916
at
Toolbox Medical Innovations
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✓ Verified May 2026
3 data sources
Profile completeness 86%
Current company
Role
Regulatory Affairs Executive | IVD Expert | PoC CLIA Waiver | OTC | Clinical Affairs | ISO 13485 | ISO 20916
Location
Washington DC-Baltimore Area, United States, United States
Who is Michaela Hoffmeyer? Overview
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Quick answer
Michaela Hoffmeyer is listed as Regulatory Affairs Executive | IVD Expert | PoC CLIA Waiver | OTC | Clinical Affairs | ISO 13485 | ISO 20916 at Toolbox Medical Innovations, based in Washington DC-Baltimore Area, United States, United States. AeroLeads shows a matched LinkedIn profile for Michaela Hoffmeyer.
Michaela Hoffmeyer previously worked as Global Head of Regulatory Affairs at Toolbox Medical Innovations and Director of Regulatory Affairs at Toolbox Medical Innovations. Michaela Hoffmeyer holds Master'S Degree, Cell/Cellular And Molecular Biology from The University Of Texas At Austin.
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Toolbox Medical Innovations
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Profile bio
About Michaela Hoffmeyer
Proven in vitro diagnostic executive with almost 20 years of experience in all segments of design controlled development of immunoassays, molecular assays, multiplex assays, point of care (PoC), integrated platforms, and instrumentation. Managed or directed major programs leading to development of +30 multiplexed assays with integration or co-development on 7 different instrument platforms.• System-level diagnostic development leader • Design control ISO 13485, 21 CFR 820.30• Regulated products (FDA, CE, CLIA, USDA) and RUO• CLIA high, moderate, waived tests, PoC, Home use• Clinical affairs, GCP, Human Subjects Research• Design transfer to manufacturing• Design verification and validation• Design history file• CAP-Accredited, CLIA-Certified, NYSDOH approved lab leadership experience, 42 CFR 493 • ISO15189 trained
Current workplace
Michaela Hoffmeyer's current company
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8 roles
Michaela Hoffmeyer work experience
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Director Of Regulatory Affairs
Toolbox is a clinical research organization and contract development and manufacturing organization. Direct regulatory and clinical activities for sponsor’s clinical studies and submissions. Ensures clinical study designs and regulatory submissions are planned, communicated, and executed per requirements. Serves as a subject matter expert (SME) on.
Nov 2021 - May 2024
Senior Advisor - Clinical Diagnostics
Cross-functional leader supporting infectious disease diagnostic product development for government and commercial clients. Supported all aspects of the diagnostic product development pipeline from R&D, through validation, and all regulatory elements including FDA de novo, 510(k), and several EUA submissions.
Nov 2018 - Nov 2021
Senior Manager, Research And Development, Lateral Flow Products
Alere (Now Abbott)
Directed a large toxicology R&D team on the development of point of care (PoC) immunoassay drug of abuse (DOA) tests from feasibility through FDA submission. Technical leader on the top two priority projects in the toxicology business unit.
Oct 2016 - Sep 2018
Manager, Research And Development
Led assay development for POC molecular diagnostics involving a novel combination of RT-PCR with colorimetric detection via lateral flow. Directed the scientific team through design-controlled development and supported FDA submission.
Oct 2015 - Oct 2016
Senior Scientist
Developed, validated, transferred, and supported pharmacogenomic (PGx) real-time PCR assay panel in CAP-Accredited, CLIA-Certified, NYSDOH-approved lab setting. Served as the knowledge expert on assay content, optimization, and troubleshooting to support clinical testing. Expert user of QuantStudio 12K Flex and ViiA7 real-time PCR platforms.
Oct 2014 - Oct 2015
Manager, Research And Development
Directed assay development for new, multiplex PCR-based molecular and immunoassays for IVD, food safety, and biodefense applications using commercial and novel instrumentation in the BSLII+ laboratory.
Sep 2009 - Nov 2013
Senior Applications Specialist/ Research Scientist
Performed multiplexed molecular and immunoassay development for commercialization. Supported regulated and academic customers in assay development best practices. Served as assay development knowledge expert to internal and external customers.
Sep 2005 - Sep 2009
2 education records
Michaela Hoffmeyer education
Master'S Degree, Cell/Cellular And Molecular Biology
The University Of Texas At Austin
Bachelor Of Science - Bs, Biological Sciences
Lsu Shreveport
FAQ
Frequently asked questions about Michaela Hoffmeyer
Quick answers generated from the profile data available on this page.
What company does Michaela Hoffmeyer work for?
Michaela Hoffmeyer works for Toolbox Medical Innovations.
What is Michaela Hoffmeyer's role at Toolbox Medical Innovations?
Michaela Hoffmeyer is listed as Regulatory Affairs Executive | IVD Expert | PoC CLIA Waiver | OTC | Clinical Affairs | ISO 13485 | ISO 20916 at Toolbox Medical Innovations.
Where is Michaela Hoffmeyer based?
Michaela Hoffmeyer is based in Washington DC-Baltimore Area, United States, United States while working with Toolbox Medical Innovations.
What companies has Michaela Hoffmeyer worked for?
Michaela Hoffmeyer has worked for Toolbox Medical Innovations, Mriglobal, Alere (Now Abbott), Mesa Biotech, Inc, and Altheadx.
How can I contact Michaela Hoffmeyer?
You can use AeroLeads to view verified contact signals for Michaela Hoffmeyer at Toolbox Medical Innovations, including work email, phone, and LinkedIn data when available.
What schools did Michaela Hoffmeyer attend?
Michaela Hoffmeyer holds Master'S Degree, Cell/Cellular And Molecular Biology from The University Of Texas At Austin.
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