Sanjukta Debroy

About Sanjukta Debroy

About MeHighly motivated individual and a team player with over 20 plus years’ work experience, primarily in Quality and Regulatory domain specializing in regulatory submissions, marketing claims analysis, quality audits and implementation of QMS in various organizations. Member of the Regulatory Affairs Professionals Society and having in-depth understanding of cGMP, GCP regulation and extensive experience in Quality & Regulatory audits and regulatory filings for USFDA. Lead Auditor for ISO 9001, ISO 13485, ISO 14155 (Clinical Trial Investigation of Medical Devices).Work ExperienceGeneral Electric (GE) Healthcare Limited Nov 2008 – till dateAs Senior Regulatory Affairs Manager Global Pre-Market Center of ExcellenceLead a team of RA professionals to monitor the regulatory status of products across GE Healthcare being marketed directly or via distributors. Responsible for managing the company’s Certificate to foreign Government (FDA) & Business documents notarization, Apostille and legalization application. Providing expertise to ensure regulatory compliance in all aspects of product development and new product introduction.Responsible for bringing legacy and new products into compliance with new MDR guidelines.Responsible for preparation of 510(k) submission Dossiers for GE Healthcare businesses. Lead the development & implementation of innovative strategies to maximize the likelihood of regulatory success.Instrumental in getting CE mark, FDA (510K) and China (NMPA) marketing clearance for at least ten newly introduced medical devices by GE HealthcareKey partner to the Research & Development teams, Regulatory and Marketing teams in achieving new product development and commercialization.Responsible for implementation of EU MDR related deliverables across product lines.Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing clinical teams and RA peersMaintained CE mark as per Medical Device Directive across product lines Lead projects across the functions with an approach to meet quality and compliance throughout the product lifecycle.Managed and executed preapproval compliance activitiesPerformed internal audit at regular intervalsResponsible for working in a cross functional role including interactions with clinical, manufacturing and quality regarding (GCP, GMP) compliance.Successfully handled audits from various regulatory agencies like FDA, EU Notified Body, MHLW / PAL and also MDSAP (Medical Device Single Audit Program)

Experience

1. Ra Director Global Premarket Center of Excellence

   GE医疗

   Sep 2023 — Present · Bengaluru, IN

Education

• University of Calcutta

  Microbiology, General

• INSTITUTE OF CLINICAL RESEARCH PROFESSIONALS (INDIA)

  Post Graduate Diploma in Clinical Research, Clinical Research

  2007 — 2009

• University of Calcutta

  Masters of Science, Microbiology and Immunology

• Patha Bhavan, Kolkata

  High School, Physical Sciences

Skills

• Clinical Trials
• Quality System
• Glp
• U.s. Food and Drug Administration (Fda)
• Gmp
• Quality Assurance
• Regulatory Filling with Fda
• Regulatory Requirements
• Validation
• Biotechnology
• Ce Marking
• Regulatory Submissions
• Iso 13485
• Medical Devices
• Clinical Research
• Fda
• Gcp
• Biopharmaceuticals
• Regulatory Affairs
• Lifesciences
• Biomedical Engineering
• Microbiology