Angela Brown

Angela Brown Email and Phone Number

Owner @ Chapel Hill, NC, US
Chapel Hill, NC, US
Angela Brown's Location
Raleigh-Durham-Chapel Hill Area, United States, United States
About Angela Brown

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

Angela Brown's Current Company Details
Topflight

Topflight

Owner
Chapel Hill, NC, US
Angela Brown Work Experience Details
  • Topflight
    Owner
    Topflight
    Chapel Hill, Nc, Us
  • Self-Employed
    Independent Consultant
    Self-Employed Aug 2024 - Present
  • Topflight
    Owner
    Topflight Mar 2022 - Present
    Provider 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.
  • Compass & Quill, Llc
    Owner/Principal Consultant
    Compass & Quill, Llc Jan 2017 - Present
  • Exactech
    Senior Director, Compliance And Remediation
    Exactech Mar 2022 - Aug 2024
    Gainesville, Fl, Us
  • Icon Plc
    Director, Regulatory Affairs
    Icon Plc Dec 2018 - Sep 2023
    Dublin, Ie
  • Halloran Consulting Group, Inc.
    Senior Consultant
    Halloran Consulting Group, Inc. Apr 2015 - Jan 2017
    Boston, Massachusetts, Us
  • Plasma Surgical, Inc.
    Vice President Ra/Qa
    Plasma Surgical, Inc. Sep 2012 - Apr 2015
    Roswell, Ga, Us
  • Bard Medical Division
    Director, Regulatory Affairs
    Bard Medical Division Aug 2010 - Sep 2012
    Murray Hill, New Jersey, Us
    Manage personnel for US and OUS regulatory submissionsProvide position, guidance and training in areas of US/OUS regulatory and Import/Export registrationManage Notified Body relationship
  • Teleflex Medical
    Regulatory Affairs Manager
    Teleflex Medical Jul 2008 - Oct 2010
    Wayne, Pa, Us
    Manage 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
  • Teleflex Medical
    Regulatory Affairs Manager, International Submissions
    Teleflex Medical Oct 2004 - Jul 2008
    Wayne, Pa, Us
    Manage, 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.
  • Weck
    Regulatory Affairs Associate
    Weck Jan 1998 - Oct 2004
    Developed 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

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 21 Cfr Validation U.s. Food And Drug Administration Quality Auditing Pma Iso Strategy Gmp Regulations Quality Management V&v Change Control Iso 14971 Iso Standards Corrective And Preventive Action Cmdcas Quality Systems International Regulatory Microbiology Verification And Validation Regulatory Strategy Mdd Aimdd

Angela Brown Education Details

  • Campbell University
    Campbell University
    Health 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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