Praneeth Varma Pusapati

About Praneeth Varma Pusapati

Results-driven Regulatory Affairs and Quality Assurance professional with experience supporting regulatory submissions, clinical trial documentation, and quality system compliance across biopharma, medical device, and clinical environments. Skilled in preparing regulatory documentation, supporting IND, NDA, and 510(k) submissions, and ensuring adherence to FDA, ICH-GCP, ISO 13485, and QSR requirements.Experienced in SOP development, CAPA support, risk assessments, document control, and technical writing. Passionate about advancing healthcare innovation through regulatory excellence, quality-focused practices, and cross-functional collaboration.Open to entry-level or associate roles in Regulatory Affairs, Quality Assurance, Quality Control, and Clinical Operations.

Experience

1. Regulatory Affairs Associate

   Breegi Scientific, Inc

   Dec 2025 — Present · Boston, MA, US

   Supported preparation, compilation, and review of 510(k) premarket submission documentation in accordance with FDA regulatory requirements and applicable guidance documents.• Assisted in organizing and maintaining technical documentation, including device descriptions, intended use statements, labeling, and substantial equivalence comparisons.• Collaborated with cross-functional teams (R&D, Quality, and Manufacturing) to collect and verify data required for regulatory submissions.• Reviewed product documentation and quality records to ensure compliance with 21 CFR Part 820 Quality System Regulation (QSR) and internal quality management system procedures.• Assisted in preparing regulatory documentation and ensuring completeness and consistency across submission components prior to FDA filing.• Conducted regulatory intelligence research on FDA guidance documents, support for GSPR compliance evaluation regulatory updates, and evolving global regulatory requirements impacting medical device submissions.• Supported document control and regulatory record management activities to maintain accurate and compliant regulatory files.• Supported internal and external audits and reviewed internal documentation to verify alignment with non-conformances.• Assisted in evaluating the regulatory impact of product or documentation changes to support ongoing compliance during the product lifecycle.• Maintained awareness of relevant FDA regulations, standards, and industry best practices to support regulatory strategy and submission readiness.

Education

• GITAM Deemed University

  Bachelor of Pharmacy - BPharm, B pharmacy

  2020 — 2024

• Northeastern University

  Master's degree, Regulatory affairs