プロフィール詳細

プロジェクトを作成

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Rob F.に依頼

United States

Quality System and Regulatory professional with over 20 years of experience

プロフィール概要

Rob is a Quality System and Regulatory professional with over 20 years of experience in QMS development, deployment, and remediation in the medical device industry. His experience encompasses all components of developing and maintaining quality systems that are compliant with FDA 820, EU MDR, MDSAP, ISO 13485:2016 and ISO 9001:2015 regulatory requirements, including organizational goals, standardized practices, documentation, personnel training, and audit preparation and remediation; Possessing exceptional interpersonal, presentation, and communication skills that facilitate effective interaction with personnel at all levels of an organization, from line workers to executive management.

専門分野

• ★ Regulatory Writing
• ☆ Biotechnology & Bioengineering
• ☆ Medical Devices

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Technical Writing

Research User Research, Feasibility Study

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation, Stability/Shelf Life Testing, Material Sourcing, Product Validation, Manufacturing, Concept Development

職務経験

Sr. Regulatory Affairs Specialist

SMSbiotech Inc

11月 2020 - 7月 2021

学歴

Bachelor of Science in Applied Arts and Sciences Biology

San Diego State University

6月 1985 - 5月 1989

認定資格

• Chemistry, Manufacturing & Controls Regulatory Affairs Professional Society May 2021

  Regulatory Affairs Professional Society

  5月 2021 - 現在

• US Regulatory Essentials, Pharmaceuticals Regulatory Affairs Professional Society

  Regulatory Affairs Professional Society

  4月 2021 - 現在

• MDR Auditor Training

  Axeon

  2月 2020 - 現在