Jinali Bhavsar

About Jinali Bhavsar

Over 14 years of professional experience in international & domestic regulatory affairs. • Knowledge of US FDA CFR, Canadian, EU IVDD/IVDR regulations, guidance and laws covering their interpretations.• Working on Digital/Software product activities for Class I, Class II, Class devices includes assisting in Pre-submissions, 510(k)/PMA submissions, regulatory strategies, registration, listing, document/design change control, Medical Device Reporting, Field Corrective Action Teams, Recalls, Regulatory Change Action Process.• Expertise in Preparation and maintenance of ERC/GSPR and Technical Files mainly Class C Software and support Notified Body review, approval and audit activities of technical files.• Proficient in international product submissions, approval, renewal and maintaining International registrations, including working with teams of distributors and consultants. Specialties: • Ability to assimilate complex technical concepts and summarize for use with regulatory agencies.• Capacity for working in fast paced teams with the ability to build excellent working relationships.• Strengths - communication, negotiation, research and analytical skills.• Proficient in ISIToolbox, Predict, SharePoint, Agile Documentum, XML, Microsoft Word and Excel.

Experience

1. Regulatory Affairs Manager

   Roche

   Sep 2022 — Present · San Francisco, CA, US

   Working on Sequencing Software Class C product

Education

• Shri G S Institute of Technology & Science

  Bachelor of Pharmacy - BPharm

  2001 — 2005

• Long Island University

  Master's, Regulatory Affairs

  2008 — 2010

Skills

• Glp
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• Capa
• Regulatory Affairs
• Pharmacovigilance
• Gmp
• Regulatory Submissions
• Anda
• Creative Visualization
• Quality System
• V&V
• Clinical Trials
• Regulatory Requirements
• Standard Operating Procedure (Sop)
• Analytical Skills
• Corrective and Preventive Action (Capa)
• Validation
• Negotiation
• Change Control
• Ectd
• Gcp