Lori Pfohl
Principal Regulatory Specialist at Avanos Medical | San Antonio, Texas, United States
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Lori Pfohl is a highly accomplished Regulatory Affairs Consultant at ALKU, specializing in New Product Development (NPD) and European Union Medical Device Regulation (EU MDR) compliance within the medical device industry. With over 30 years of extensive experience, Lori has honed her expertise in navigating complex regulatory landscapes, ensuring that innovative medical devices meet stringent safety and efficacy standards. Her role involves not only the strategic oversight of regulatory submissions but also the implementation of robust quality management systems aligned with ISO 13485 standards.
At ALKU, Lori has been instrumental in leading key projects that bridge the gap between product development and regulatory compliance. She has successfully authored and submitted more than 10 510(k) applications, showcasing her deep understanding of the regulatory pathways essential for market entry. Her proficiency in Quality Management Systems (QMS) and Supplier Quality Assurance (SQA) has enabled her to enhance operational efficiencies and foster collaborative relationships with cross-functional teams.
Lori's expertise extends to Good Clinical Practice (GCP) and Clinical Quality Assurance (CQA), where she applies her analytical skills, including proficiency in Minitab, to ensure data integrity and compliance throughout the product lifecycle. Her commitment to excellence in regulatory affairs not only drives successful product launches but also contributes to the overall safety and effectiveness of medical devices in the marketplace. As a thought leader in the field, Lori continues to advocate for best practices in regulatory compliance, making her a valuable asset to ALKU and the medical device community at large.
Principal Regulatory Specialist at Avanos Medical in February 2025 to Present
Regulatory Affairs Consultant at ALKU in February 2024 to February 2025
Travel at Career Break in August 2023 to January 2024
Regulatory Affairs Team Lead at Teleflex in April 2022 to July 2023
Senior Regulatory Affairs Specialist at Teleflex in October 2009 to April 2022
Quality and Regulatory Affairs at Andersen Products in August 1990 to September 2009
Microbiologist at STS in June 1988 to August 1990
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State University of New York at Plattsburgh, BS Microbiology, September 1984 to September 1988
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Regulatory Intelligence
Technical Writing
Regulated Industry
Timelines
Technical Documentation
Regulatory Agencies
Interpersonal Communication
Sustaining Engineering
Product Design
Auditing
Tender Submissions
ISO Standards
QSR
Medical Device Directive
Environmental Monitoring
U.S. Food and Drug Administration (FDA)
Electronic Submissions
Coaching & Mentoring
Medical Device Regulation (MDR)
510(k)
Coaching
Interpersonal Skills
Regulatory Compliance
CAPA
Clinical Research
Regulatory Affairs
GMP
IND
ISO 13485
Oncology
ISO
Medical Devices
Cross-functional Team Leadership
Biotechnology
Manufacturing
FDA
ISO 14971
Validation
Sop
GLP
PMA
Quality Auditing
Change Control
Supplier Quality
Quality Management
Design Control
GCP
CQA
Quality Assurance
Lifesciences
Microbiology
Product Launch
Clinical Trials
FMEA
21 CFR Part 11
Pharmaceutics
V&V
Quality System
Quality Control
Minitab
Regulatory Submissions
CE marking
Design of Experiments
Product Development
R&D
Root Cause Analysis
Document Management
Pharmaceutical Industry
Six Sigma
Sterilization
Biomedical Engineering
Biocompatibility
Complaint Management
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Discover more about Avanos MedicalWhat is Lori Pfohl email address?
Email Lori Pfohl at [email protected] and [email protected]. This email is the most updated Lori Pfohl's email found in 2026.
How to contact Lori Pfohl?
To contact Lori Pfohl send an email to [email protected] or [email protected]. (updated on August 27, 2024)
What company does Lori Pfohl work for?
Lori Pfohl works for Avanos Medical
What is Lori Pfohl's role at Avanos Medical?
Lori Pfohl is Principal Regulatory Specialist
What is Lori Pfohl's Phone Number?
Lori Pfohl's phone (214) ***-*326
What industry does Lori Pfohl work in?
Lori Pfohl works in the Medical Devices industry.
Lori Pfohl Email Addresses
Lori Pfohl Phone Numbers
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