SL

Singh, Lalit Raj

Also known as: Lalit

Fiducie Life, Tulip Diagnostics Pvt Ltd a revvity Company, Kurukshetra University, Hemwati Nandan Bahuguna Garhwal University, National Innovation Foundation

ORCID iD 0000-0002-8825-9564
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About

Senior Quality Assurance and Regulatory Affairs professional with 15+ years of experience across Medical Devices, IVDs, Pharmaceuticals, Herbal Formulations, and regulated healthcare products. Expertise in Quality Management Systems (QMS), Regulatory Affairs, global compliance, audit readiness, supplier quality management, technical documentation, and product lifecycle management.
Proven experience in EU MDR/IVDR, ISO 13485, CDSCO Medical Device Rules, USFDA 21 CFR Part 820, GMP compliance, EDQM requirements, CAPA systems, validation, and global regulatory submissions. Demonstrated leadership in handling cross-functional teams, regulatory audits, compliance programs, and international market authorization activities.
Successfully managed 46+ quality and regulatory audits within two years while supporting strategic compliance initiatives across global regulated markets.

Employment

  • Fiducie Life Principal Consultant
    2026 - Present
  • Tulip Diagnostics Pvt Ltd a revvity Company QMS Compliance cum Regulatory Head
    2024 - 2026
  • National Innovation Foundation Research Associate
    2023 - 2024
  • Shantikunj Pharmacy (Dev Sanskriti Vishwavidyalaya) Consultant and Assistant Professor
    2014 - 2023
  • SD Bio Standard Diagnostics Pvt Ltd Assistant Manager DRA
    2010 - 2014

Education

  • Kurukshetra University M PharmaPharmaceutical
    2008 - 2010
  • Hemwati Nandan Bahuguna Garhwal University B Pharma
    2004 - 2008

Projects & Funding

Projects & funding information is unavailable.

Publications (18)