Profile Details

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Hire Usman M.

Germany

USD 50 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

New Product Development Manager

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

February 2019 - November 2021

Product Development Engineer

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

October 2017 - February 2019

Associate Medical Device Consultant

ASD Industries

September 2015 - September 2016

Education

Masters in Biomedical Engineering

Technische Hochschule Lübeck, Lübeck, Germany.

October 2016 - January 2019

Bachelors of Science in Mechanical Engineering

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

September 2011 - August 2015

Certifications

• Certification details not provided.