You are looking for a professional challenge that allows you to work in a start-up environment in order to develop International Regulatory Affairs activities ?
You have acquired experience with international submissions (including FDA) in the medical devices industry and you want to take the lead on Regulatory Affairs Projects for the international market?
Plus One can offer you this great challenge:
Our Client is is a medical devices company active in gastro-enterology. The company is dedicated to the development of innovative devices providing new means of therapeutic interventions for gastroenterologists. It is a spin-off from Université libre de Bruxelles, based on a collaboration between the engineers of the engineering school and the gastroenterologists from Erasme Hospital.
The product has been recently CE marked and in order to develop their activities on an international level, they are looking for an International Regulatory Affairs Manager .
At a product level, International Regulatory Affairs Manager ensures that all regulatory requirements relevant to the foreign countries, starting with US market (documentation, respect of standards, directives, etc.) are properly applied and documented.
At a company level, he / she ensures alignment between the regulatory constraints, the company policies and the actual activities in order to maintain the highest level of quality of the products.
He/ she is the official contact point with FDA (or other international authorities) and other stakeholders regarding regulatory and quality topics, including product vigilance.
Your key responsibilities:
Our Client offers a full-time permanent position along with an attractive remuneration package.
The position is based in Belgium (2 locations: Brussels and/or Gosselies and with flexibility for homeworking) and has an international scope.
You will be part of a highly skilled and dynamic team headed by a solid management team.
This is an agile start-up company culture focused on values of autonomy, commitment, team-spirit and excellence.