プロフィール詳細

プロジェクトを作成

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Jose A.に依頼

United States

Freelance Medical Device professional with over 25 years of experience implementing QMS systems and RA compliance

プロフィール概要

Behind every successful medical device registration, there is a team of experts working hard to ensure it meets regulatory requirements. As a Quality and Regulatory Executive with more than 25 years of experience, I am committed to enhancing regulatory processes. My strong communication skills have enabled me to build positive connections with regulatory agencies like the FDA and Notified Bodies. Over the course of my career, I have successfully created and executed quality systems on a global scale. Additionally, I have a track record of effectively submitting medical device product applications in various markets worldwide, such as the EU, Canada, APAC, EMEA, and Latin American countries.

専門分野

• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Marketing
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Safety Testing
• ☆ Medical Device Validation
• ☆ Medical Device Design
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Clinical Trials
• ☆ Regulatory Affairs
• ☆ Skills Training
• ☆ Regulatory Writing
• ☆ Medical Device Regulatory Writing
• ☆ Premarket Notification/510(k) Submission

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review

Consulting Go-to-Market Strategy Consulting, Operations Consulting, Scientific and Technical Consulting, Regulatory Consulting, Manufacturing Consulting

Product Development Stability/Shelf Life Testing, Product Evaluation, Material Sourcing, Product Validation, Manufacturing, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development, Product Launch Support, Packaging Design, Prototyping

職務経験

Founder/CEO

Quality and Regulatory Affairs Solution, LLC

5月 2022 - 現在

Director of QA/RA

Peerbrodge Health

3月 2021 - 現在

Regulatory Affairs Specialist

LENSAR

3月 2012 - 3月 2021

QA/RA Manager

LaserSight Technologies

3月 2004 - 3月 2012

学歴

M.S Clinical Nutrition

Maryland University of Integrative Health

8月 2018 - 5月 2021

B.S Biology

University of Puerto Rico

8月 1987 - 5月 1992

認定資格

• GCP for Clinical Investigations of Devices

  CITI

  1月 2021 - 現在

• Protecting Human Research Participants

  National Institutes of Health Office of Extramural Research

  9月 2015 - 現在

• Health Insurance Portability and Accountability Act (HIPAA)

  ProTrainings

  3月 2021 - 3月 2022