Prachi Bhatnagar

About Prachi Bhatnagar

A regulatory enthusiast, fascinated by the ever-evolving beauty of this field, my peers…

Experience

1. Regulatory Affairs Specialist

   Philips

   Oct 2023 — Present · Pune, IN

   Payroll-Cyient• Developed and executed regulatory strategies for product registrations and timely renewal of licenses, supporting global market access and business continuity.• Coordinated communication with regulatory authorities; followed up on product notifications, registrations, and responses to inquiries.• Supported registration processes by collecting, organizing, and reviewing in-country documentation; partnered with manufacturers and internal teams for submission readiness.• Led the impact assessment of upcoming regulations and provided product-specific analysis to guide compliance planning.• Delivered presentations identifying regulatory gaps and proposing mitigation strategies; contributed to process improvements, including reducing complaint intake time from 1 week to 48 hours.• Prepared agendas, meeting notes, and follow-ups; provided administrative support to the regulatory team while contributing to cross-functional projects.• Participated in training sessions to stay current on global compliance standards and regulatory frameworks.• Played a key role in Phase 3 of the project by developing a high-impact slide that secured organizational buy-in for the next phase and contributed to increased profitability.Contributed in sections for 510K submission, independently authored Design and Development documents.Executed the validation testing, IFU updates, and contributed to drafting Design Input documents.