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Angela has 30+ years of regulatory affairs and quality assurance experience in the medical device industry. Angela has experience in successful global regulatory strategy for new and existing product lines, developing quality systems processes, and working across multiple commercial and R&D functions. Previously worked on MDR implementation and global destination labeling. Experienced in strategic regulatory approaches for bringing compliance, current industry standards and business plans forward. In her previous roles Angela developed excellence in identifying key company initiatives, full program planning, global resource management and regulatory strategies. Angela served as Vice President of Regulatory Affairs and Quality Assurance at Plasma Surgical, Inc. where she played a key role addressing strategic initiatives, obtaining worldwide regulatory approvals, implementing and maintaining quality systems to meet global compliance requirements, and leading and developing staff members. Prior to Plasma Surgical, Angela held contributing roles for more than 15 years C. R. Bard as the Director of Regulatory Affairs and at Teleflex as a Senior Manager of Regulatory Affairs in various regulatory and quality roles including sterilization, environmental monitoring, audits, compliance, training, design controls, US and OUS regulatory submissions and recall assessment and management. Angela earned a Bachelor of Science in Biology from Campbell University in Buies Creek, North Carolina. She is an active member the Regulatory Affairs Professional Society (RAPS) where she has published papers and has been a guest speaker at multiple events.Specialties: Medical Devices, Regulatory Affairs, Quality Assurance, Quality Systems, MDR, Destination Labeling
Topflight
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OwnerTopflightChapel Hill, Nc, Us
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Independent ConsultantSelf-Employed Aug 2024 - Present
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OwnerTopflight Mar 2022 - PresentProvider of canine or equine athlete sport massages, as well as canine strength and conditioning by Angela Brown, CCMT & CESMT, to teams looking to improve their competitive excellence.
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Owner/Principal ConsultantCompass & Quill, Llc Jan 2017 - Present
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Senior Director, Compliance And RemediationExactech Mar 2022 - Aug 2024Gainesville, Fl, Us -
Director, Regulatory AffairsIcon Plc Dec 2018 - Sep 2023Dublin, Ie -
Senior ConsultantHalloran Consulting Group, Inc. Apr 2015 - Jan 2017Boston, Massachusetts, Us -
Vice President Ra/QaPlasma Surgical, Inc. Sep 2012 - Apr 2015Roswell, Ga, Us -
Director, Regulatory AffairsBard Medical Division Aug 2010 - Sep 2012Murray Hill, New Jersey, UsManage personnel for US and OUS regulatory submissionsProvide position, guidance and training in areas of US/OUS regulatory and Import/Export registrationManage Notified Body relationship -
Regulatory Affairs ManagerTeleflex Medical Jul 2008 - Oct 2010Wayne, Pa, UsManage personnel responsible for Adverse Event Reporting and Recall ManagementManage the Global Recall ProcessLiaison for the company addressing Notified Body concerns and requriements, and manager Notified Body transitions -
Regulatory Affairs Manager, International SubmissionsTeleflex Medical Oct 2004 - Jul 2008Wayne, Pa, UsManage, design, develop and maintain regulatory submissions to facilitate international registration approvals/compliance for all products in the following markets: Canada, Europe, Pacific Rim, Asia, South and Latin AmericaDevelop, implement and support processes, procedures and preparation of technical files, design dossiers, STED documents, and foreign registration submissions Manage ISO, CE Marking, global licensing, etc. -
Regulatory Affairs AssociateWeck Jan 1998 - Oct 2004Developed a strong working knowledge of regulatory and quality system requirements: FD&C Act; 21 CFR; ISO 13485; CMDR; MDD 93/42/EEC, etc. Obtained submission experience, label approval, literature approvals, regulatory strategy preparation, and FDA direct/indirect internation
Angela Brown Skills
Angela Brown Education Details
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Campbell UniversityHealth Science
Frequently Asked Questions about Angela Brown
What company does Angela Brown work for?
Angela Brown works for Topflight
What is Angela Brown's role at the current company?
Angela Brown's current role is Owner.
What is Angela Brown's email address?
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What is Angela Brown's direct phone number?
Angela Brown's direct phone number is +191969*****
What schools did Angela Brown attend?
Angela Brown attended Campbell University.
What skills is Angela Brown known for?
Angela Brown has skills like Fda, Iso 13485, Medical Devices, Quality System, Regulatory Affairs, Regulatory Submissions, Medical Device Directive, Design Control, Quality Assurance, Capa, Ce Marking, Cross Functional Team Leadership.
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