Summary
Overview
Work History
Education
Skills
Additional Information
Languages
Timeline
Generic
William STEINER

William STEINER

Echirolles,France

Summary

Specialist of Regulatory Affairs for medical devices with 5 years of experience in the industry, combined with a background in the pharmaceutical field and a strong aptitude for acquiring new knowledge. Able to both coordinate or collaborate in a team and operate autonomously, I demonstrate a strong sense of organization and proven skills in resolving CE compliance customer requests and in preparing and approving technical and regulatory documents.

Overview

5
5
years of professional experience

Work History

Educational Speaker

Claude Bernard University
10.2019 - Current
  • Preparation of educational slides for students in Pharmacy regarding medical device industry.
  • Conference at the University.



Regulatory Affairs Specialist

Becton Dickinson
09.2020 - Actuel

Realize B2B opportunities by providing regulatory requirements ensuring high-quality customer service:

  • Review requests within the day
  • Answer within 3 days (Resolution, Sending for support, Redirection)
  • Respond to urgent request during the day
  • Report gaps of compliance to EMEA direction and provide the options of resolution.


Facilitate the initiation of business relationship by developing Technical Data Sheets (TDS) that covers MDS Portfolio:

  • Distribute tasks to MDS EMEA Regulatory team and perform weekly alignment meetings
  • Definition of a tracking tool and metrics
  • Participate to the preparation of the BDx Procedure and lead the preparation of Template to facilitate the preparation and review of TDS.
  • Train interns to the TDS preparation
  • Perform TDS preparation through data collect, completion from multifunctional teams (RA, QA, R&D, B2B, Marketing, Product StewardShip)
  • Prepare then review drafts with the Marketing representative and Regulatory Affairs representative before final submission in our electronic system for control.
  • Upload and new approved versions and manage updates in the repository intended to customers.
  • Provide inputs and options regarding process for updating TDS depending on NoC and customer feedback.

Education

Doctor of Pharmacy - Pharmaceutical Sciences

Claude Bernard University
Lyon
11-2020

Master of Science - Technical And Regulatory Aspects of Medical Device

Polytech Lyon
Lyon
08-2019

Skills

  • Resolution of CE mark requests
  • Investigation on eu MDR regulation
  • Preparation, Review and Approval of Technical and Regulatory documents
  • Customer Service
  • Education of new members or lay persons

Additional Information

  • Competitor at tennis
  • Enjoy biking, running
  • Nature, cooking, reading


Languages

English
Professional Working
Spanish
Limited Working
Italian
Limited Working

Timeline

Regulatory Affairs Specialist

Becton Dickinson
09.2020 - Actuel

Educational Speaker

Claude Bernard University
10.2019 - Current

Doctor of Pharmacy - Pharmaceutical Sciences

Claude Bernard University

Master of Science - Technical And Regulatory Aspects of Medical Device

Polytech Lyon
William STEINER