プロフィール詳細

プロジェクトを作成

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Usman M.に依頼

Germany

Medical Devices Consultant | Compliance, Quality, and Risk Management, Regulatory Affairs

プロフィール概要

Career Profile Regulatory Affairs Specialist with 5+ years of experience, in the creation and compilation of regulatory submissions to regulatory bodies for medical device companies. Career Highlights Preparation, compilation, and submission of regulatory applications for product approvals domestically and internationally. (FDA’s medical device regulations, EU MDD and MDR, ISO standards). Communicate with Systems Engineers, Design Engineers and Quality Engineers to understand product concepts and capture the learned material in regulatory submissions. Maintain and update CE Technical Documentation and participation in quality systems audits. Review, write and contribute toward departmental SOPs and policies.

専門分野

• ★ Medical Devices
• ☆ Biomedical Engineering
• ☆ European Medical Device Regulation (MDR)

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Technical Writing, Copywriting, Newswriting

Research Market Research, User Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Predictive Modeling, Statistical Analysis, Algorithm Design-Non ML, Data Visualization, Big Data Analytics, Data Processing, Data Insights

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

職務経験

New Product Development Manager

Biomechanics and Implants Technology Research Laboratory, FORBIOMIT, Rostock, Germany.

2月 2019 - 11月 2021

Product Development Engineer

Biomechanics and Implants Technology Research Laboratory, FORBIOMIT, Rostock, Germany.

10月 2017 - 2月 2019

Associate Medical Device Consultant

ASD Industries

9月 2015 - 9月 2016

学歴

Masters in Biomedical Engineering

Technische Hochschule Lübeck, Lübeck, Germany.

10月 2016 - 1月 2019

Bachelors of Science in Mechanical Engineering

Mirpur University of Science and Technology, M.U.S.T, Mirpur, Pakistan

9月 2011 - 8月 2015

認定資格

• 認定資格の詳細は未入力です。