Mark Duryea
Sr. Systems Analyst-Quality & Regulatory Systems at B.Braun | Bethlehem, Pennsylvania, United States
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Mark Duryea is a seasoned professional with over 40 years of experience in Quality and Regulatory Systems, specializing in applications, validation, and compliance with FDA CFR21 and EMEA regulations. As a Senior Systems Analyst for Quality & Regulatory Systems at B.Braun Medical Inc., Mark plays a pivotal role in ensuring that the company’s systems meet stringent regulatory standards while also driving efficiency and innovation within the organization. His expertise encompasses a wide array of specialties, including OpenText LiveLink, ECM Documentum, eCTD submissions, and XML labeling, which are critical for maintaining compliance in the highly regulated medical device industry.
In his current position as North America Project Manager for Quality & Regulatory Systems, Mark leads key initiatives aimed at enhancing the quality management systems and regulatory compliance frameworks at B.Braun. He is instrumental in overseeing change control processes, system administration, and validation efforts, ensuring that all systems are not only compliant with ISO 13485 and GMP standards but also optimized for performance. His deep understanding of CAPA (Corrective and Preventive Action) processes and validation methodologies allows him to effectively manage complex projects that require meticulous attention to detail and adherence to regulatory requirements.
Mark’s ability to navigate the intricate landscape of medical device regulations, combined with his technical proficiency in document management systems, positions him as a valuable asset to B.Braun. His commitment to continuous improvement and quality assurance drives the success of projects that ultimately enhance patient safety and product efficacy in the medical field. Through his leadership and expertise, Mark Duryea exemplifies the integration of quality systems with regulatory compliance, ensuring that B.Braun remains at the forefront of the medical device industry.
Sr. Systems Analyst-Quality & Regulatory Systems at B.Braun in July 2003 to Present
Senior Systems Analyst at Ortho Clinical Diagnostics in January 1981 to April 2003
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DeSales University, Bachelor of Applied Science (BASc), Finance, General, October 1992 to October 1994
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Change Control
Livelink
GxP
FDA
System Administration
21 CFR Part 11
Documentum
Troubleshooting
Computer System Validation
Validation
CAPA
GMP
V&V
ISO 13485
Quality Assurance
Sop
Medical Devices
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What is Mark Duryea email address?
Email Mark Duryea at [email protected]. This email is the most updated Mark Duryea's email found in 2026.
How to contact Mark Duryea?
To contact Mark Duryea send an email to [email protected].
What company does Mark Duryea work for?
Mark Duryea works for B.Braun
What is Mark Duryea's role at B.Braun?
Mark Duryea is Sr. Systems Analyst-Quality & Regulatory Systems
What is Mark Duryea's Phone Number?
Mark Duryea's phone (215) ***-*612
What industry does Mark Duryea work in?
Mark Duryea works in the Pharmaceuticals industry.
Mark Duryea Email Addresses
Mark Duryea Phone Numbers
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