Michael Petrini

About Michael Petrini

Regulatory Affairs and Compliance professional with demonstrated leadership developing global, progressive, strategies obtaining marketing authorizations for Medical Devices (Class I, II, and Biologics, and Drugs (Rx and OTC).

Experience

1. VP (Executive), Regulatory Affairs - Patient Care Solutions

   GE HealthCare

   Dec 2021 — Present · Seattle, WA, US

   Lead a team of global Regulatory Affairs professionals. Senior leadership team member for the Patient Care Solutions integrated businesses and Global Regulatory Affairs. Connect the business vision with regulatory strategies, policies, and positions that will put life-improving and lifesaving technologies in the hands of caregivers and patients. Advocate and shape emerging regulatory policies through external engagement. Working with integrated solutions such as patient monitoring, anesthesia, respiratory, diagnostic cardiology, maternal and infant care, acute care, and digital, software, and AI/ML solutions.

Education

• The Johns Hopkins University

  Masters, Bioscience Regulatory Affairs

  2010 — 2012

• Brigham Young University

  Bachelors of Science, Neuroscience, Chemistry

  2002 — 2008

Skills

• Medical Devices
• Italian
• Capa
• Premarket Approval (Pma)
• Regulatory Affairs
• Validation
• Cgmp
• Cross-Functional Team Leadership
• Ingredients
• Glp
• Usp
• Biotechnology
• Six Sigma
• Chemistry
• 510(K)
• Training
• Global Regulatory Compliance
• Pre-Submissions
• Change Control
• Quality Control
• Gmp
• Quality Assurance
• Root Cause Analysis
• Sap
• Continuous Improvement
• Registration
• Leadership
• Quality Management
• R&D
• Management
• Quality System
• Quality Systems
• Manufacturing
• Pharmaceutical Industry
• Sop
• Fda
• Strategic Planning
• Product Development