BACKGROUND
FOCUS AREAS
Extensive global expertise in regulatory compliance, quality management systems, FDA inspections, FDA remediations, auditing, CAPA, complaint handling, supplier management, and postmarket surveillance activities.
AUDIT EXPERTISE
FDA & NB Remediation
FDA Inspection Preparation
CAPA & Nonconforming
ISO 14971/Risk Management
Complaint Handling and Medical Device Reporting
Purchasing and Supplier Controls
Clinical Evaluation and Performance Reports
Postmarket Surveillance
Yogindra Dellow has decades of experience as a highly accomplished and result-oriented professional 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 extensive global expertise in strategy development and deployment, regulatory compliance, quality management systems, FDA inspections, FDA remediations, auditing, CAPA, complaint handling, supplier management, and postmarket surveillance activities.
Supported a wide range of medical device manufacturers with submissions, remediation activities, and to understand both the new EU Medical Device Regulation and the EU In Vitro Diagnostics Regulation. Also played an integral role in developing several of the medical device training courses.
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EDUCATION:
MS degree in Regulatory Affairs for Drugs, Biologics and Medical Devices with Regulatory Compliance Concentration, Northeastern University, Boston, MA
BS degree, Rutgers UniversityCERTIFICATIONS:
MDSAP Trainer Certification and Instructor
Lead Auditor Certification and Instructor
Exemplar Global – QMS Lead Auditor and Instructor
ASQ Certified Quality Auditor
EU MDR and CE Marking Certification and Instructor
ISO 13485:2016 Lead Auditor Certificate & Instructor
Quality Systems and Industry Standards Certificate
QSA International Quality Management Certifications -
REGULATORY PROFESSIONAL EXPERIENCE:
As a Senior Corporate Regulatory Compliance for B. Braun Medical Inc., hosted national and international FDA inspections as well as Notified Body and customer audits. 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 a Management Representative for PreAnalytix and Corporate Regulatory Affairs & Compliance Manager for BD Corporate, was responsible for a company’s entire quality management system. Managed and supervised quality auditors from worldwide facilities, and managed regulatory agency inspections, customer audits, and third-party evaluations. Monitored, evaluated, and interpreted global regulatory requirements, including those for the EU, US, Canada, Australia, Japan, SAEAN, and PAHO. Led both internal and external agency and FDA inspections that resulted in positive outcomes and recommendations for the company’s continued certifications.Training:
Recognized expert in delivering quality and/or regulatory classroom and virtual training as well as developing course materials and content for training programs. Some of the developed training programs include internal auditing program, CAPA, supplier management, ISO 13485, 21 CFR 820, QSIT, Canadian MDR, Korean FDA, Japan’s MHLW, EU MDR and EU IVDR, and ANVISA.AUDIT EXPERTISE:
EU MDD/EU MDR
EU IVDD/EU IVDR
21 CFR 820
ISO 13485 & ISO 9001
MDSAPPOSTMARKET EXPERTISE:
FDA & NB Remediation
FDA Inspection Preparation
CAPA & Nonconforming
ISO 14971/Risk Management
Complaint Handling and Medical Device Reporting
Purchasing and Supplier Controls
Clinical Evaluation and Performance Reports
Postmarket Surveillance
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