<html> <body> Alicia Hemphill </body> </html>

Alicia Hemphill

VP of Regulatory Affairs

Alicia has over 20 years of experience in bringing Class II and III medical devices and IVDs from concept through to commercialization.

Expert in developing aggressive, creative and proven clinical/market approval strategies and negotiations by leveraging new regulatory programs with regulators in written, verbal and face to face settings. Demonstrated strong leadership of high functioning regulatory, cross-functional and interdepartmental teams to drive the approval of new products to global markets. Extensive experience implementing Company policies, processes and procedures that transform Regulatory Operations and organizational interfaces. Specializing in leading teams that increase collaboration across functional organizations (esp. technical, clinical, manufacturing, labeling, legal and marketing). Highly skilled at identifying and solving complex regulatory and organizational challenges that hinder approval of global market applications. Demonstrates passion for building functional human systems within the context of organizational effectiveness.

Alicia at a Glance

Audit Expertise

  • 21 CFR 820
  • 21 CFR 211
  • EU MDD/EU MDR
  • IVDD/IVDR

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • ISO 14971/Risk Management
  • PRODUCTION
    • ISO 14971/Risk Management
    • Production and Process Control
    • Document Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Document Controls
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA & NB Remediation

Regulatory Submissions

  • USA, Canada, Europe and Australia
  • 510(k), IDE, Q-Sub, and PMA Submissions
  • CE Marking - Technical Files, Design Dossiers, Risk Management Files, Essential Requirements Checklist, Clinical Evaluation Reports

Industry Experience

  • Alicia has held leadership positions at top global device manufacturers, including W.L. Gore, Abbott, and OsteoMed

Education

  • Master of Science, Engineering Technology, Murray State University, Kentucky

Certifications

  • Regulatory Affairs Certificate (RAC)
  • Regulatory Affairs Professional Society (RAPS) since 2006

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Alicia’s Areas of Expertise

A few of Alicia’s noteworthy accomplishments include:

  • US Regulatory – Responsible for multiple IDEs (including multi-country early feasibility clinical study and traditional pivotal study), PMA-S (including real-time and 180-day submissions), original 510(k) applications, 30-day notices for supplier and manufacturing changes), and direct FDA and Notified Body Q-submissions and negotiations.
  • OUS Regulatory – Responsible for the development, submission and approval of design dossiers, Canadian licenses for new devices, China new device approvals, PMDA approvals, and Latin American and Australian approvals.

Highlighted Experience

  • Lead the Q-submission activities for two proprietary development projects
  • Sponsor and Project Lead to create, plans and execute OsteoMed’s first Retrospective Post Market Clinical Follow-Up (PMCF) study to meet the EU MDR Class III submission deadlines
  • Successful execution of the regulatory due-diligence activities for M&A portfolio acquisitions/sales
  • Initiator and Sponsor for the gap analysis, remediation and establishment of policies, procedures and processes to transition OsteoMed’s product portfolio for Medical Device Regulations (MDR) by 2020
  • W.L. Gore and Associates representative to the ADVAMED PMA Working Group.
  • Winner of the Abbott Division Quality Excellence Team Award for co-leadership in developing additional regulatory and quality requirements required to transition manual site labeling process from paper and CD to internet, online help, and remote database access.
  • Obtained an Early Feasibility Breakthrough Designation for a new technology device novel cardiovascular device.

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