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Michael Loiterman Location
Pittsburgh, PA, US
Michael Loiterman Work
2023 -now Vice President, Regulatory Affairs @
2021 -2023 Founder and Chief Executive Officer @ Hallom Communications
2016 -2021 U.S. Head of Regulatory Affairs, Quality Assurance and Quality Control @
2015 -2016 Director, Regulatory Affairs, Quality Assurance and Compliance @
2014 -2014 Associate Director, Regulatory Affairs and Quality Assurance @
Michael Loiterman Education
Northwestern University 2001-2004
1991-1995
Michael Loiterman Skills
Process Improvement
Strategy
Healthcare Compliance
Life Sciences
Quality Assurance
Quality System
Quality Control
Pharmacovigilance
Cross Functional Team Leadership
Product Development
Commercialization
ISO 13485
Transparency
Manufacturing
Design Control
Clinical Trials
Validation
CAPA
Regulatory Affairs
Strategic Planning
Product Launch
ISO
GMP
Leadership
PMA
Start Ups
FDA
Management
Medical Devices
Quality Management
Regulatory Requirements
Sunshine Act
Change Control
IDE
ISO 14971
510k
Verification and Validation V&V
Ncmr
Healthcare
Hde
Corrective and Preventive Action Capa
Medical Device Directive
Premarket Approval Pma
Quality Auditing
u.s. Food and Drug Administration Fda
Regulatory Submissions
Standard Operating Procedure Sop
Market Development
u.s. Food and Drug Administration
Verification and Validation
Standard Operating Procedure
Corrective and Preventive Action
Premarket Approval
Michael Loiterman Summary
Michael Loiterman, based in Pittsburgh, PA, US, is currently a Vice President, Regulatory Affairs at ZOLL Medical Corporation. Michael Loiterman brings experience from previous roles at Hallom Communications, Richard Wolf Medical Instruments Corporation, Medacta USA, Inc. and Pinnacle Biologics, Inc.. Michael Loiterman holds a 2001 - 2004 Northwestern University. With a robust skill set that includes Process Improvement, Strategy, Healthcare Compliance, Life Sciences, Quality Assurance and more. Michael Loiterman has 1 emails and 2 mobile phone numbers on RocketReach.
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