Profile Details

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Hire Viky Gilles Daniel V.

United States

USD 150 /hr

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma

Profile Summary

Guru providing regulatory affairs services to the medical device / medtech, biotech, and pharmaceutical industries. Qualification supported by over 11 years of experience in the field, including 6 years working at the US Food and Drug Administration (FDA - ORA and CDRH), and a solid educational background with a Master’s of Science (MS) in Biomedical Engineering, MS in Pharmacy, Regulatory Affairs Certificate, and a Regulatory Affairs Certification (RAC Global). Driven by a keen interest in the field, developed expertise in and acquired substantial knowledge on the US, EU, and global regulations of medical devices, pharmaceutical products (drugs, biologics), and combination products. I can also leverage my FDA background for cosmetics, dietary supplements, and foods as well. The services I can assist with include: PRE-MARKET RELATED - Product idea/concept brainstorming - (to) - Product development - (to) - Regulatory strategy planning - (to) - Pre-market application preparation and submission - (to) - market authorization - (to) - commercialization - (to) - Post-market total product lifecycle management - Technology/Product approvability evaluation for technical and regulatory due diligence including regulatory requirement review (product classification, guidance documents, applicable international standards, guidelines, etc…) - Design control activities (i.e. 21 CFR 820.30) - Product risk management (i.e. ISO 14971) - Usability / Human Factors studies - Technical writing for application types: 510(k) (traditional, abbreviated, de novo), PMA, HDE, IDE, CE Mark, NDA, ANDA, 505(b)(2), IND (CTD and eCTD) etc… - Correspondence with regulatory authorities (US FDA, EU EMA, Notified Bodies, TGA, Canada, and others) (pre-submission meetings, 513(g), Request For Designation (RFD) submissions, response letters, information requests, PMA 30 Day notices, Site Change submissions, annual reports, etc…) - FDA Registration and listing POST-MARKET RELATED - Quality system development, improvement, management, record keeping and maintenance, gap analysis (including technical writing - drafting and reviewing records, work instructions (WI), standard operating procedures (SOPs), and other quality system related documents) - Facility audits (mock FDA/MDSAP inspections) against US 21 CFR 820 (Medical Devices), 21 CFR Part 4 (Combination Products), ISO 13485 - Manufacturing / Production and Process Controls: Design transfers to production, manufacturing line qualification, process validation, etc… - Complaint handling including recall initiation and processing, and adverse event reporting (i.e. MDR, AER) - Corrective and Preventive Actions (CAPA) Handling including change controls, non-conformance/deviation reviews etc… - Compliance related correspondence with authorities (deficiency remediation updates, FDA Form 483 Observations, Warning Letters, Untitled Letters, Recalls 806 Reports, MDR 803 Reports, Regulatory Meetings, Injunctions, Seizures, Civil Money Penalties, etc...) GENERAL REGULATORY AFFAIRS - Regulatory project management - Regulatory/Compliance strategy development - Workshops and training / Startup coaching - US FDA Imports requirements - WHO, IMDRF, MDSAP, ICH related activities.

Subject Matter Expertise

• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Biotechnology & Bioengineering
• ☆ Biomedical Engineering
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Implants
• ☆ Wearable Technology
• ☆ Medical Device Prototyping
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ☆ Clinical Trials
• ☆ IRB Applications
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Data Management
• ☆ Clinical Trial Site Selection & Monitoring
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Medical Genetics
• ☆ Immunogenetics
• ☆ Regulatory Affairs
• ☆ Pharmaceutical Management
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Clinical Evaluation Reports (CER)
• ☆ Premarket Notification/510(k) Submission
• ☆ Investigational Device Exemption (IDE)
• ☆ PreMarket Approval (PMA) Applications
• ☆ CMC Documentation
• ☆ NDA/BLA Applications
• ☆ Nonclinical Study Documentation
• ☆ Clinical Trial Documentation
• ☆ Clinical Trial Protocol Writing
• ☆ Clinical Study Reports
• ☆ Investigational New Drug (IND) Application Writing

Services

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Creative Writing

Research Market Research, Gap Analysis

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Manufacturing, Product Launch Support, Device Fabrication

Work Experience

Co-Founder / Senior Regulatory Consultant

Confinis LLC

October 2018 - Present

Senior Regulatory Consultant

Confinis AG

September 2016 - September 2020

Regulatory Specialist / Volunteer

World Health Organization (WHO)

July 2016 - August 2017

COMPLIANCE OFFICER

U.S. Department of Food and Drug Administration (FDA)

November 2011 - September 2016

Consumer Safety Officer

Office of Regulatory Affairs

January 2010 - November 2011

Epidemiologist

U.S. Centers for Disease Control and Prevention (CDC)

November 2009 - January 2010

Education

Global Regulatory Affairs Certification

Global Regulatory Affairs Certification

January 2014 - January 2015

Drug Regulatory Affairs Certificate

University of Florida

January 2010 - January 2012

Master of Science (MS), Pharmacy

University of Florida

January 2010 - January 2012

Master of Science (MS), Biomedical engineering

University of Miami

January 2008 - January 2010

Bachelor of Science (BS), Biomedical engineering

University of Miami

January 2004 - January 2008

Certifications

• Regulatory Affairs Professionals Society

  Global Regulatory Affairs Certification

  January 2014 - January 2015

Publications

BOOK

Viky Verna (2023). The Combination Products Handbook. Susan Neadle.