Gary Brogan Email and Phone Number
Gary Brogan work email
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Gary Brogan personal email
Gary Brogan is a Vice President of Global Regulatory and Clinical Affairs at WallabyPhenox. He possess expertise in iso 13485, quality assurance, medical devices, fda, design control and 15 more skills.
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Vice President Of Global Regulatory And Clinical AffairsWallabyphenoxCounty Galway, Ireland
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Vice President Of Global Regulatory And Clinical AffairsWallabyphenox May 2023 - PresentIrvine, California, Us -
Director, Phenox LtdPhenox Jan 2021 - PresentBochum, Nrw, De -
Director Of Regulatory And Clinical AffairsPhenox Mar 2016 - Jan 2021Bochum, Nrw, De
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Director Of Quality And Regulatory AffairsArc Devices Ltd Apr 2015 - Mar 2016Established the Quality Department in a new facility in Galway. This included the implementation and successful ISO13485 registration. Managed all aspects of US market clearance for two 510(k) Non-Touch Infra-red Thermometers. -
Vice President Regulatory Affairs480 Biomedical, Inc. Jul 2013 - Apr 2015Member of the Senior Management team of two sister companies with direct ownership of the regulatory function for both. Developed the EU and US regulatory strategies for all the products, ranging from bioresorbable scaffolds to foams used for peripheral embolization. Novel regulatory strategies employed included denovo 510k, Humanitarian Device Exemptions and Early Feasibility IDE clinical studies.
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Vp Of Regulatory And Clinical AffairsCappella Medical Devices Limited Jan 2007 - Jul 2013Quality, Regulatory and Clinical responsibility to bring a nitinol coronary stent through the CE Marking process, including the completion of a pre-market clinical trial. Subsequent market release activities involved country registrations, reimbursement submissions, product training and proctoring and the management of both post market clinical trials and registries.
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Qa/Ra ContractorBoston Scientific Sep 2006 - Jan 2007Marlborough, Ma, UsContract work to re validate a number of product lines to revised company requirements, stemming from an FDA warning letter. -
Design / Quality AssuranceLabcoat Limited Aug 2004 - Sep 2006Design assurance responsibility to ensure that two concept stent coating machines were subjected to full Design Control as per ISO13485.
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Project Quality EngineerBoston Scientific May 1999 - Aug 2004Marlborough, Ma, UsThe quality lead for the transfer of 8 Wallstent product lines from the US to the Galway plant. Tasks involved all aspects from due diligence to first lot to stock from Galway Plant.
Gary Brogan Skills
Gary Brogan Education Details
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Trinity College DublinBioengineering -
Institute Of Technology, SligoQuality Management
Frequently Asked Questions about Gary Brogan
What company does Gary Brogan work for?
Gary Brogan works for Wallabyphenox
What is Gary Brogan's role at the current company?
Gary Brogan's current role is Vice President of Global Regulatory and Clinical Affairs.
What is Gary Brogan's email address?
Gary Brogan's email address is ga****@****ces.com
What schools did Gary Brogan attend?
Gary Brogan attended Trinity College Dublin, Institute Of Technology, Sligo.
What skills is Gary Brogan known for?
Gary Brogan has skills like Iso 13485, Quality Assurance, Medical Devices, Fda, Design Control, Ce Marking, Iso 14971, Capa, Regulatory Affairs, Vascular, Clinical Research, Medical Device Directive.
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