Brad Strasser
Owner and Principal Consultant at Strasser Engineered Solutions, LLC | Austin, Texas, United States
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Brad Strasser is a seasoned professional in the field of Global Regulatory Affairs, currently serving as the Owner and Principal Consultant at Strasser Engineered Solutions, LLC. With a robust background that spans the US, Latin America, EU, and Asia Pacific, Brad has honed his expertise in navigating the complex regulatory landscapes that govern the medical device industry. His extensive experience includes collaborating with government and regulatory bodies to ensure compliance and facilitate the successful launch of innovative medical devices.
At Strasser Engineered Solutions, Brad specializes in providing comprehensive consulting services that encompass Regulatory, Quality, and Clinical Affairs. He has successfully built and managed a US regulatory team, developing strategic frameworks for submissions that align with FDA 510(k) requirements and other regulatory pathways. His leadership in implementing the EU Medical Device Regulation (MDR) has been pivotal in guiding clients through the intricacies of compliance, ensuring that their products meet stringent safety and efficacy standards.
Brad’s proficiency in design control, ISO 14971 risk management, and Failure Mode and Effects Analysis (FMEA) further underscores his commitment to quality and safety in medical device development. His Regulatory Affairs Certification (US) highlights his dedication to maintaining the highest standards in the industry. Through his work, Brad not only enhances the regulatory readiness of his clients but also fosters a culture of continuous improvement and innovation within the medical device sector. As he continues to lead key projects at Strasser Engineered Solutions, Brad remains a trusted partner for organizations seeking to navigate the evolving regulatory landscape and achieve their business objectives.
Owner and Principal Consultant at Strasser Engineered Solutions, LLC in April 2020 to Present
Vice President of Quality and Regulatory Affairs at Senseye, Inc. in May 2022 to Present
Director of Regulatory, Quality, & Clinical Affairs at Paradromics Inc in August 2021 to May 2022
Sr. Project Manager at Paradromics Inc in March 2021 to August 2021
Regulatory Affairs Manager at Zimmer Biomet in July 2018 to April 2020
Regulatory Affairs Manager - EU MDR/IVDR at Zimmer Biomet in May 2017 to July 2018
Project Manager, Regulatory Affairs at Zimmer Biomet in October 2016 to May 2017
Manager, U.S. Regulatory Affairs at LDR in January 2015 to October 2016
Regulatory Affairs Project Manager at LDR in May 2012 to January 2015
Senior Regulatory Affairs Analyst at Integra LifeSciences in December 2011 to May 2012
Specialist, Regulatory Affairs at Ascension Orthopedics in January 2011 to December 2011
Associate, Regulatory Affairs at Zimmer in October 2009 to January 2011
Senior Engineer I, Global Hip Development at Zimmer in July 2007 to October 2009
HSE/PSE Intern at Faurecia in June 2006 to June 2007
Collaborative Undergraduate Research Student at Zimmer in February 2006 to May 2007
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FDA 510(k) Submissions
Design Control
New Product Development
FDA
Medical Devices
Regulatory Affairs
FMEA
Spine
Product Development
Commercialization
Regulatory Submissions
ISO 14971
CAPA
Quality System
Medical Device Directive
Biomedical Engineering
ISO 13485
Failure Mode and Effects Analysis (FMEA)
U.S. Food and Drug Administration (FDA)
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What is Brad Strasser email address?
Email Brad Strasser at [email protected] and [email protected]. This email is the most updated Brad Strasser email found in 2026.
What is Brad Strasser phone number?
Brad Strasser phone number is +15126736592 and +15124539282.
How to contact Brad Strasser?
To contact Brad Strasser send an email to [email protected] or [email protected]. If you want to call Brad Strasser try calling on +15126736592 and +15124539282. (updated on October 30, 2024)
What is Brad Strasser net worth?
Brad Strasser has an estimated net worth of $750,000 to $999,999
What company does Brad Strasser work for?
Brad Strasser works for Strasser Engineered Solutions, LLC
What is Brad Strasser's role at Strasser Engineered Solutions, LLC?
Brad Strasser is Owner and Principal Consultant
What industry does Brad Strasser work in?
Brad Strasser works in the Research Services industry.
Brad Strasser Email Addresses
Brad Strasser Phone Numbers
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