Regulatory Affairs Manager

Objective

The Regulatory Affairs Manager ensures that the regulatory submissions are performed according to the relevant legislation and guidelines for clinical trials with medical devices and in agreement with the client.

Major responsibilities

  • Responsible for the set-up and execution of regulatory related tasks within the designated Clinical research projects (during start-up, progress and closure) in compliance with the regulatory requirements throughout involved countries with reference to the relevant legislations, applicable guidelines and genae SOPs;
  • Act as an intermediary between the different parties involved, which may include the genae Clinical Project Manager, Competent Authority, Ethics Committee and the client;
  • Pro-actively identify regulatory related issues and set-up strategies to handle this efficiently;
  • Keep regulatory submission timelines and control budget in close cooperation with the client and genae Clinical Project Manager;
  • Guide and support members of the project team to ensure adherence with regulatory  requirements, timelines and budget;
  • Coordinate and cooperate with third party vendors if applicable (e.g., consultants, translation agencies etc.);
  • Update the Department Head/senior Regulatory Affairs Manager on project progress and any major issues;

Qualifications
The candidate has excellent planning and organizational skills with proven time-management skills. He/She is proficient in MS Office, detail-oriented and pro-active with a strong analytical mind. The candidate is fluent in English, by preference in more languages.

Required experience
Relevant experience in Clinical Research, by preference in medical devices. Regulatory affairs hands-on experience preparing, reviewing, and submitting regulatory documentation.

Required education
Higher educational degree (Bsc or MSc) in a medical or science-related field

​​​​​​​Locations
We are looking for a Regulatory Affairs Manager for our Belgian entity (Antwerp

 


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