Juli Cronan

About Juli Cronan

Strategic business leader with over 20 years’ experience working in Regulated labeling…

Experience

1. Labeling Director

   Philips

   Oct 2020 — Present · San Diego County, CA, US

   Responsible for development and implementation of global regulatory labeling strategies for all Philips Image Guided Therapy products • Supports the overall Philips Enterprise labeling strategies • Provides tactical guidance to program teams, prepare Product Labels, with product specific Regulatory partners, as lead label negotiations with Health Authorities.• Provide strong strategic guidance on Global labeling regulations, requirements, competitor labeling, and labeling trends• Participates in the product development team for early development product to provide labeling leadership in developing target labeling concept to guide the design and analysis plan for clinical trials.• Manages labeling negotiations with FDA and EMA; draft responses to Health Authority queries and revised labeling for submissions; track labeling-related Health Authority requests and responses• Prepares the submission ready labeling documents including the IFU and packaging artwork. Maintains and tracks labeling documents in the labeling repository and electronic system as appropriate.• Monitors the worldwide regulation and standard changes pertaining to Labeling requirements• Represent Labeling during review of medical and commercial materials to support external scientific communications, ensure scientific and medical accuracy, adequacy of data and information supporting claims, and compliance with applicable laws and regulations.• Provide regulatory guidance according to the assessment of approved product labeling, references, applicable regulations and regulatory environment materials (i.e. enforcement actions, advisory comments, and guidance documents for the medical device industry, etc.)• Ensure compliance with applicable laws, regulations and Health Authority guidelines, as well as internal audit document requirements• Contribute and influence enterprise-wide labeling solutions.• Lead, Manage, Develop, and Empower of team of direct reports.

Education

• Arizona State University

  Bachelor of Arts (B.A.)

  1988 — 1992

Skills

• Personnel Management
• Medical Devices
• Management
• Cross-Functional Team Leadership
• Fda
• Design Control
• Dmaic
• Leadership
• Process Excellence
• Six Sigma
• Design of Experiments
• Project Management
• Iso 13485
• Quality System
• V&V
• Product Labeling
• Process Improvement
• Validation