feedback

Regulatory Affairs & Quality Assurance Expert Consultant

Obelis

Brussels, Belgium

Objective:

To contribute to the smooth operation of the Regulatory Affairs & Quality Assurance Department as well as support the department’s and team’s performance, KPIs and daily activity.

Main Duties:

  • Provide professional, high level and smooth client service;
  • Perform various Notification work associated with the RA/QA department;
  • (Product Classification, Pre-Market Notification, National Registration, Free Sales Certificate Application, GMDN Code Verification, Communications with EU Authorities, etc) at the highest level;
  • Follow-up on tasks assigned to him as well as coordinate tasks assigned to a small team (more than 5);
  • Ensure regulatory and scientific research on requirements;
  • Support the development and design of a new method, system and resource;
  • Support preparations for Management & Board Meetings;
  • Assistance to Managers, Department Managers and/or Unit Directors;
  • Provide internal trainings on department related matters;
  • Contribute to online and offline publications;
  • Contribute to the implementation of ISO 9001:2008 and ISO 13485:2003;
  • Participate to Obelis events.

Requirements:

Education

  • MA Degree in Economy, European law, Pharmacy, Chemistry or Quality Management Systems (or similar).

Experience

  • 3 -5 years’ experience in project management and Quality Management systems (QA/RA);
  • Experience managing a team;
  • Professional experience in EU Administration is considered an asset;
  • Scientific background is considered an asset;
  • Familiarity with Cosmetics and or Medical Devices is considered an asset.

Language(s)

  • Fluency in English (written & oral);
  • Any other languages are always a plus.

Computer Skills

  • Proficiency at Microsoft Word, Excel, PowerPoint, Outlook.

Desired skills & Competencies:

  • Strong knowledge of Quality Management systems;
  • Exceptional ability to manage the execution of multiple projects without error, and with high attention to detail;
  • Customer and Solution oriented;
  • Strong analytical abilities;
  • Ability to prioritize, coordinate and manage tasks;
  • Excellent time-management skills;
  • Ability to assume responsibilities;
  • High adaptability, flexibility, dedication supported by a positive ‘can-do’ attitude;
  • Strong oral and writing skills to be able to communicate effectively internally and externally;
  • Ability to structure workflow within a team;
  • Ability to take own initiatives;
  • Ability to motivate team members;
  • Be able to and willing to travel in/out of the European Union.

Apply Now

Don't forget to mention EuroBrussels when applying.

© EuroJobsites

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies