Profile Details

Create Project

★★★★★

☆☆☆☆☆

USD 75 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Bogdan M.

Romania

USD 75 /hr

Global Regulatory Affairs in Medical Device industry

Profile Summary

I am an PhD Chemical engineer with proven experience in quality assurance and regulatory affairs. Currently I am the J. Manager Global Regulatory Affairs responsible for B Braun Hospicare based in Sligo, Ireland, Europe. The medical devices are part of the wound management area including all risk classes (class 1 - class 3). I have proven to be a professional and dedicated worker within the industry of medical devices. My experience is described below: -Preparation and maintenance of Export registration files on the basis of the CE (under MDD and MDR) marking file for assigned products groups -Support for preparation of the CE marking specific documentation in co-operation with Global Regulatory Affairs -Preparation of documentation for customer specific requests (tender, etc.) in co-operation with Global Regulatory Affairs -Perform worldwide new registrations and renewals, as required -Coordinating the RA meetings -Updating/Creating RA SOPs -Being part of the ISO 13485 audit as the backroom administrator -Working with complex countries for registration of Medical Devices such as China, Russia and APAC countries -Change control assessment management -Evaluate the impact of changes on local current & ongoing registrations in collaboration with local organizations -Update databases -Implementation of other tasks arising from the current needs of the Regulatory Affairs Department -Supports task forces and specific RA related projects Skills: Document Management · Regulatory Affairs · Medical Devices · ISO 13485

Subject Matter Expertise

• ☆ Medical Devices
• ☆ Medical Device Regulatory Consulting
• ☆ European Medical Device Regulation (MDR)
• ☆ ISO 13485

Services

• Writing
• Consulting
• Product Development

Writing General Proofreading & Editing

Consulting Business Strategy Consulting, Go-to-Market Strategy Consulting

Product Development Quality Assurance & Control (QA/QC)

Work Experience

J. Manager Regulatory Affairs

B Braun

April 2021 - Present

Quality manager

Aquatim

January 2018 - April 2021

Chemical engineer

Aquatim

September 2014 - April 2021

Education

Doctorate

Politehnica University of Timisoara, Romania, Europe

October 2016 - November 2020

Master degree

Politehnica University of Timisoara, Romania, Europe

September 2014 - July 2016

Bachelor Environmental Chemical Engineering

Politehnica University of Timisoara, Romania, Europe

September 2010 - July 2014

Certifications

• Medical devices regulation (MDR 2017/745)

  AlphaMed Consulting Ltd Ireland

  June 2021 - Present