プロフィール詳細

プロジェクトを作成

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Viky Gilles Daniel V.に依頼

United States

Global Regulatory Affairs Consultant - FDA - Medical Device - Pharma

プロフィール概要

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.

専門分野

• ☆ 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

サービス

• 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

職務経験

Co-Founder / Senior Regulatory Consultant

Confinis LLC

10月 2018 - 現在

Senior Regulatory Consultant

Confinis AG

9月 2016 - 9月 2020

Regulatory Specialist / Volunteer

World Health Organization (WHO)

7月 2016 - 8月 2017

COMPLIANCE OFFICER

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

11月 2011 - 9月 2016

Consumer Safety Officer

Office of Regulatory Affairs

1月 2010 - 11月 2011

Epidemiologist

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

11月 2009 - 1月 2010

学歴

Global Regulatory Affairs Certification

Global Regulatory Affairs Certification

1月 2014 - 1月 2015

Drug Regulatory Affairs Certificate

University of Florida

1月 2010 - 1月 2012

Master of Science (MS), Pharmacy

University of Florida

1月 2010 - 1月 2012

Master of Science (MS), Biomedical engineering

University of Miami

1月 2008 - 1月 2010

Bachelor of Science (BS), Biomedical engineering

University of Miami

1月 2004 - 1月 2008

認定資格

• Regulatory Affairs Professionals Society

  Global Regulatory Affairs Certification

  1月 2014 - 1月 2015

出版物

BOOK

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