プロフィール詳細

プロジェクトを作成

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Katherine W.に依頼

United Kingdom

Medical Device Senior Regulatory Affairs Consultant with experience working at strategic and manufacturing levels

プロフィール概要

Recent experience working as a senior regulatory affairs consultant, and with EU and UK-centric manufacturers, for strategic regulatory gap analyses, roadmaps, and operations: UKCA and CE (MDD/MDR) markings for submissions of all risk classes to third party assessors, training, due diligence. Domaines of expertise: medical devices (Class I to III implantable), and drug-device combination products. Orthopaedics, urology, neurology. My LinkedIn profile: https://www.linkedin.com/in/katherinewan1/

専門分野

• ★ Medical Implants
• ★ Neurology
• ★ Orthopedics & Sports Medicine
• ☆ Wound Care

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Technical Writing, Copywriting

Research Market Research, Fact Checking, Gray Literature Search

Consulting Scientific and Technical Consulting, Regulatory Consulting

Product Development Formulation

職務経験

Director

Pangaea / Panthalassa Regulatory Consultancy

2月 2022 - 現在

Regulatory Affairs Senior Specialist

Voisin Consulting Life Sciences (VCLS)

6月 2021 - 2月 2022

Regulatory Affairs Specialist

Clinimed

7月 2020 - 6月 2021

Regulatory Affairs Specialist

Zimmer Biomet

11月 2018 - 7月 2020

Regulatory Affairs Associate

Stryker

6月 2016 - 9月 2017

学歴

BSc (Hons) (First Class)

Canterbury Christ Church University

6月 2016 - 6月 2016

認定資格

• Internal Auditor ISO 13485:2016

  BSI Training Academy

  12月 2020 - 現在