Eric Bannon Email and Phone Number
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A dynamic executive with extensive global experience in successfully implementing creative regulatory and clinical strategies from development through commercialization. Experience in multiple therapeutic areas including Endoscopy, Orthopedics and Gastroenterology and Metabolic Diseases. Recognized for taking a hands on approach while building high performance teams to support company growth. Experienced in successfully developing, leading and implementing complex plans and directing successful regulatory filings. Results driven manager with the ability to adapt and anticipate changes in plan execution. EXPERTISE• Global Regulatory Strategy • Executing US Pre-Sub, IDE and 510(k) submissions • Early and mid-stage start ups • Strategic and tactical implementation of clinical initiativesREGULATORY ACHIEVEMENTS• Coordinated and led the successful approval of multiple IDEs • Developed and executed successful strategies that led to early CE Mark approvals for class II and III devices • Successfully navigated worldwide approvals for initiation of pre and post-market clinical trials in US, EU, Canada and South America• Negotiated and completed over 40 510(k) submissions that led to successful market launchCLINICAL STRATEGY AND IMPLEMENTATION• Built a clinical operations team to support execution of 350 patient trial• Successful completion of OUS first in human trials to support procedural development efforts and establish acceptable safety profile• Integration of CMS recommended reimbursement measures into spinal stenosis trial that led to significant coverage of trial execution costs• Coordination of multiple clinical programs to support type 2 diabetes indication in the US and EU
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Vice President Of Clinical And Regulatory AffairsAlvamed, Inc. Feb 2019 - PresentUsProvider of Clinical and Regulatory consulting services to a wide variety of medical device companies across multiple therapeutic platformsCreate and execute regulatory strategies for clients through the FDA Pre-Submission process resulting in clear submission pathwayDraft and file IDE for numerous devices in advance of US clinical evaluation Support De Novo filing for novel devices to expand indications for use Primary oversight for investigational plan creation for multiple medical device companies to support US and OUS studies Provide clinical operations support for multiple US IDE and OUS feasibility and First in Human Trials for novel technologiesStaff oversight of personnel creating Clinical Evaluation Reports for EU MDD and MDR Regulation -
ConsultantMed-Reg Associates, Llc Sep 2017 - Feb 2019Assisting medical device companies with regulatory strategy, submissions and clinical affairs implementation in both the US and International markets
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Vice President Of Regulatory, Clinical, QaFractyl Laboratories Inc. Jul 2011 - Sep 2017Lexington, Ma, Us -
Corporate Regulatory And Clinical ConsultantGlobus Medical Jan 2011 - Apr 2011Audubon, Pa, UsRegulatory Support for Class III Spinal ImplantSupporting PMA Pivotal Study -
Vp Regulatory And Clinical AffairsFacet Solutions 2005 - 2010UsClass III Spinal Implant CompanyCompleted all IDE SubmissionsRan Pilot and Pivotal Trials -
Vice President Regulatory And Clinical AffairsNdo Surgical 2001 - 2004UsResponsible for all FDA CommunicationSuccessfuly Completed IDE Trial leading to 510(k) International Clinical Trial Experience -
Vice President Of Regulatory, Clinical, QaCortek 2000 - 2001Completed Pre-IDE and IDE for Class III DeviceNegotiated FDA Protocol Approvals
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Vice President Regulatory, Clinical, QaInnovasive Devices 1992 - 2000Mutiple 510((k) ApprovalsInternational RegistrationsPost Market Studies
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Regulatory And Qa ManagerSmith And Nephew Endoscopy 1989 - 1992Filed Multiple 510(k)sInternational RegistrationsQuality Engineering Supervision
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Manager Of Regulatory And QaLook, Inc. 1987 - 1989
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Qa EngineerCr Bard, Usci 1982 - 1987
Eric Bannon Skills
Eric Bannon Education Details
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University Of MaineMicrobiology -
Massachusetts Institute Of TechnologyMicrobiology
Frequently Asked Questions about Eric Bannon
What company does Eric Bannon work for?
Eric Bannon works for Alvamed, Inc.
What is Eric Bannon's role at the current company?
Eric Bannon's current role is Medical Device Consultant Specializing in Regulatory and Clinical Affairs.
What is Eric Bannon's email address?
Eric Bannon's email address is eb****@****reg.com
What is Eric Bannon's direct phone number?
Eric Bannon's direct phone number is +143575*****
What schools did Eric Bannon attend?
Eric Bannon attended University Of Maine, Massachusetts Institute Of Technology.
What skills is Eric Bannon known for?
Eric Bannon has skills like U.s. Food And Drug Administration, Medical Devices, Regulatory Affairs, Clinical Affairs.
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