Tim Bright Email and Phone Number
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Tim is a seasoned compliance specialist who has devoted his career to the medical device industry for over three decades. With his partners at Echelon, Tim is currently helping clients all over the world to resolve compliance challenges as well as getting market clearance and sales access for growing companies! He was previously responsible for ensuring a progressive strategy and timely device registrations for all CONMED product lines, Internationally as well as managing International Regulatory and Quality System Compliance personnel activities. He was most recently responsible for International Regulatory Affairs and Compliance for CONMED Orthopedic and CONMED International facilities. Tim was with CONMED for nearly 18 years and has held positions in Quality, Regulatory and Compliance. Tim has extensive experience as host to audits by US FDA, foreign governments and various Registrars. His previous experience includes Quality Assurance Manager for Wilson-Cook Medical (Cook Endoscopy), and Senior Quality Engineer for Argon Medical (a Bristol-Meyer Squibb company). Tim is a Senior member of American Society of Quality and Society of Manufacturing Engineers.
Isoaid
View- Website:
- isoaid.com
- Employees:
- 18
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Sr. Director Ra And Qa And SterilizationIsoaidFlorida, United States
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Sr. Director Ra/Qa/SterilizationIsoaid Sep 2019 - PresentDirector of Regulatory Affairs & Quality Assurance, IsoAid, leading global manufacturer/supplier of Brachytherapy products used in the treatment of localized cancers.
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Founding PartnerEchelon Biomedical Consulting May 2017 - PresentInterested in improving your organization's quality management system? Expanding distribution of your product to the US, Europe or to other region? Need to respond to FDA enforcement actions? No matter the quality system issue EBC can work with you to develop a remediation plan to best fit your needs.
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PrincipalBright Quality Solutions Sep 2016 - PresentProviding tailored Quality and Regulatory solutions, third party QMS audits, Gap Analyses and Risk Assessments to the Medical Device and Life Sciences industries.
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Director Of Industry SolutionsCompliancequest Mar 2019 - Sep 2019Tampa, Florida, UsProviding best in class eQMS solutions for clients wanting to make the smarter, connected, cloud based and scalable choice for compliance! -
Director Corporate International Regulatory AffairsConmed Corporation May 2015 - Aug 2016Largo (Tampa Bay), Fl, Us -
Director, Global Regulatory Compliance/Govt. AffairsConmed Corporation Jun 2012 - Aug 2016Largo (Tampa Bay), Fl, UsInterpret, execute and recommend modifications to organization policies that impact all ConMed products and facilities.Supports global GMP and ISO compliance audit programs for ConMed Corporation service centers and facilities worldwide.Directs the GMP compliance support for ConMed Corporation service centers and facilities worldwide.Serve as a regulatory compliance and government affairs resource to the organization by providing input and opinions that are in compliance with applicable rules and regulations, foreign and domestic. Manage and drive systems to closure that are already established with the quality program.Establish quality management and regulatory-specific requirements and processes that meet all applicable QMS requirements, including definition, documentation, and implementation (training).Lead and provide expert advice in the areas of compliance to QSR, JPAL, CMDR, MDD, and ISO13485.Monitor and report on all regulatory compliance activities within the ConMed Organization.Collect process metrics, analyze process performance, and identify areas for improvement for Quality Management and Regulatory Compliance.Lead improvement efforts using industry standard techniques, such as Lean Six Sigma.Support assigned due diligence and new business integration activities as required.
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Global Director, Regulatory ComplianceConmed Corporation Jun 2010 - Jun 2012Largo (Tampa Bay), Fl, Us
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Director Qs ComplianceConmed Corporation Sep 1999 - Jun 2010Largo (Tampa Bay), Fl, Us
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Quality ManagerWilson Cook Medical 1991 - 1998
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Sr. Quality EngineerArgon Medical 1985 - 1991
Tim Bright Skills
Tim Bright Education Details
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University Of California, Davis -
St. Petersburg College
Frequently Asked Questions about Tim Bright
What company does Tim Bright work for?
Tim Bright works for Isoaid
What is Tim Bright's role at the current company?
Tim Bright's current role is Sr. Director RA and QA and Sterilization.
What is Tim Bright's email address?
Tim Bright's email address is to****@****aol.com
What is Tim Bright's direct phone number?
Tim Bright's direct phone number is +172748*****
What schools did Tim Bright attend?
Tim Bright attended University Of California, Davis, St. Petersburg College.
What are some of Tim Bright's interests?
Tim Bright has interest in Private Pilot/aircraft Owner, Sports Car Racing, Photographer, Guitarist.
What skills is Tim Bright known for?
Tim Bright has skills like Fda, Iso 13485, Medical Devices, Quality System, Gmp, Capa, Design Control, Quality Assurance, Iso, Quality Management, Quality Auditing, Iso 14971.
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