Jeanette Rigolizzo

About Jeanette Rigolizzo

Diversified experience across aspects of the in vitro diagnostics industry, leading to a…

Experience

1. Regulatory Affairs Manager

   Roche

   Jun 2015 — Present

   Responsible for onsite Regulatory Compliance of on-market products, including:\\\\n- change evaluation\\\\n- process validation documentation review\\\\n- agency submissions, communications and periodic reporting\\\\n- inspection support and strategy\\\\n- labeling and CAPA support.\\\\n\\\\nResponsible for registration of new products and product changes with FDA and with EU Notified Body (IVDD and IVDR).\\\\nEvaluate processes and implement improvements, including in reporting processes and change evaluations.\\\\nImplement embedded Regulatory training within Operations, and serve as a conduit for communication between Operations and Regulatory Affairs.\\\\n \\\\n\\\\n \\\\n \\\\n\\\\n \\\\n

Skills

• Organization
• Technology Transfer
• Good Laboratory Practice (Glp)
• Lims
• Error Correction
• Medical Devices
• Molecular Biology
• U.s. Title 21 Cfr Part 11 Regulation
• Drug Development
• Change Control
• Validation
• 21 Cfr Part 11
• Project Portfolio Management
• Data Analysis
• Business Process Improvement
• Laboratory Information Management System (Lims)
• Glp
• Fda
• Assay Development
• Analysis
• Hplc
• Capa
• Process Improvement
• R&D
• Trackwise
• Corrective and Preventive Action (Capa)
• Technical Writing
• Gmp
• Life Sciences
• U.s. Food and Drug Administration (Fda)
• Lifesciences
• Pharmaceutical Industry
• Biopharmaceuticals
• Biotechnology