Jordan Greenberg

About Jordan Greenberg

Accomplished high risk and active implantable medical devices professional with extensive experience and demonstrated proficiencies in:• US, EU and global laws, regulations, standards and guidances (US FDA CFR, GCP, ICH, ISO, MEDDEV, EU MDR, EU AIMDD, EU MDD) related to quality management systems; clinical evaluation process and writing Clinical Evaluation Reports (CERs) and related documents; pre- and post-market clinical studies; risk assessment and management; capture and analysis of passive and proactive post-market surveillance data.• Developing a clinical evaluation process procedure, work instructions and templates for documents complying with EU MDD, AIMDD, and MEDDEV 2.7/1 Rev 4 requirements. Performing gap assessment on existing clinical evaluation process and requirements imposed by EU MDR. Enacting modifications to processes, procedures and templates to adhere to EU MDR. • Writing and reviewing CERs (complying with MEDDEV 2.7/1 Rev 3 and 4) in support of submission for CE Mark to obtain EU market clearance, recertification, and to support indication and labeling changes. Interacting with Notified body auditors regarding CER content and processes.• Designing, conducting and overseeing pre-market clinical trials, post-market studies, post-market surveillance activities. Writing clinical study reports for 510(k)s and PMA supplements.• Dissemination of scientific data via publications in peer-reviewed journals, and poster and podium presentations at various congresses. Partnering with sales and marketing to create informational materials supporting claims and company strategy for devices.• Key therapeutic areas and disorders in which performed clinical trials, provided clinical data for risk assessment, and written CERs include: Neuromodulation (chronic pain disorders and movement disorders); Cardiovascular (structural heart and heart valve disorders); Peripheral vascular occulsive disorders; Cardiac rhythm management.

Experience

1. Associate Director, Clinical Affairs, International

   BD

   May 2022 — Present · Tempe, AZ, US

Education

• Bradley University

  MA, Community Clinical Psychology

• Indiana University Bloomington

  BA, Psychology

• Finch University of Health Sciences/Chicago Medical School

  PhD, Health Psychology

  2001

Skills

• R&D
• Management
• Protocol
• Medical Devices
• Clinical Research
• Capa
• Quality System
• Ctms
• Regulatory Submissions
• Iso 13485
• Clinical Development
• Cardiology
• Biomedical Engineering
• Fda
• U.s. Food and Drug Administration (Fda)
• Research
• Biotechnology
• Post Market Surveillance
• Program Management
• Gcp
• Clinical Trials
• Regulatory Affairs
• Clinical Evaluation Reports
• Product Development