Angie Barker

Experience

1. Medical Affairs Manager - Clinical Evaluation, Evidence Generation, & Scientific Communications

   BD

   Oct 2022 — Present

   Participates on cross-functional EU MDR project teams.• Collaborates with Quality, Regulatory and Medical Writers providing clinical expertise on medication delivery system device use. • Provides clinical expertise for medical device Clinical Evaluation Plans and Clinical Evaluation Reports. • Provides clinical expertise for medical device Post Market Surveillance and Periodic Safety Update Reports. • Review and provide clinical input into Post Market Clinical Follow-Up Plans (PMCF) and provides support for the execution of required PMCF activities including worldwide clinician surveys. • Provides clinical expertise for evidence generation (safety/efficacy/usability) to meet EU MDR requirements. • Participates on cross-functional EU MDR teams to address Notified Body queries. Responsible for ensuring the safety and efficacy within the Medical Delivery Solutions (MDS) products worldwide. Supporting the work required for EU MDR registrations, and providing the clinical users’ perspective for new product development and changes/enhancements to current products.

Education

• University of North Carolina at Chapel Hill

  Bachelor of Science

• University of Cincinnati

  Master of Science

  2010 — 2012