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Yogindra Dellow

Sr. Director, Quality and Regulatory Consulting

Yogindra Dellow has two decades of experience in the life sciences field. She is well versed in medical device and pharmaceutical laws and regulations/standards, including FDA 21 CFR 820, 806, and 803; MDSAP; EU MDD/MDR; EU IVDD/IVDR; ISO 13485; and ISO 9001. Her expertise also includes quality management systems, auditing, CAPA, complaint handling, process validation, document control, supplier management, and postmarket surveillance activities.

For Oriel STAT A MATRIX, Yogindra has supported a wide range of medical device manufacturers to understand both the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation. Yogindra has also played an integral role in developing the Oriel STAT A MATRIX IVDR training course.

Yogindra at a Glance

Audit Expertise

  • EU MDD/EU MDR
  • IVDD/IVDR
  • 21 CFR 820
  • ISO 13485
  • MDSAP

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • ISO 14971/Risk Management
  • PRODUCTION
    • ISO 14971/Risk Management
    • Process Validation
    • Production and Process Control
    • Supplier Controls
    • Document Controls
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Controls
    • Document Controls
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA & NB Remediation

Regulatory Submissions

  • USA, Japan, Canada, Europe and Australia
  • 510(k), IDE, Q-Sub, and PMA Submissions
  • CE Marking - Technical Files

Education

  • MS degree in Regulatory Affairs for Drugs, Biologics and Medical Devices with Regulatory Compliance Concentration – Northeastern University, Boston, MA

Language

  • English, Spanish

Certifications

  • MDSAP Trainer Certification
  • Lead Auditor Certification
  • QSA International Quality Management Certification

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Yongindra’s Areas of Expertise

  • Regulatory – As Senior Corporate Regulatory Compliance for B. Braun Medical Inc., hosted national and international FDA inspections as well as Notified Body and customer audits. Also developed, managed, coordinated, and performed internal and supplier audit programs for US, Europe, and Caribbean facilities, including conducting mock FDA audits to verify inspection readiness.
  • Quality Management Systems – As Quality System Manager, Management Representative for PreAnalytix, was responsible for a company’s entire quality management system. Also managed and supervised quality auditors from worldwide facilities, and managed regulatory agency inspections, customer audits, and third-party evaluations.
  • Training – Developed training programs (both classroom-based and online) for BD’s internal auditing program, CAPA, supplier management, and other quality system regulations, including ISO 13485, 21 CFR 820, QSIT, Canadian MDR, Japan’s MHLW, EU MDD and IVDD, and ANVISA.

Highlighted Experience

As Corporate Regulatory Affairs & Compliance Manager for BD Corporate:

  • Monitored, evaluated, and interpreted global regulatory requirements, including those for the EU, US, Canada, Australia, Japan, SAEAN, and PAHO. Also completed regulatory compliance gap assessments for new and updated regulations, including MDSAP, ISO 13485:2016, and ANVISA.
  • Led both internal and external agency and FDA audits that resulted in positive recommendations for the company’s continued certification to ISO 13485 and ISO 14001.

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