Regulatory Affairs Coordinator

We are looking for an Regulatory Affairs Coordinator, who will support the team members in the execution of regulatory strategies. Interested in this challenging opportunity?

You can apply by sending your resume to: sarah.leten@professionals.randstad.be or call me: 0489/789720

• 
  A university, bachelor’s degree or equivalent,
• 0-2 years of work experience, preferably but not limited to regulatory affairs (Technical File/Design Dossier/Technical Dossier preparations or submissions)
• Good command of database and spreadsheet software,
• Excellent written and verbal communication skills in English,
• Creative and advanced computer skills: Excel (mandatory), Power Point, One Note, Microsoft Team,
• Analytical, self-motivated, energetic, well organized, and self-disciplined person,
• Attention to detail,
• Capacity to work autonomously,
• Ability to take on diverse tasks, good organizational skills.

As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extra’s like:

• Meal vouchers of 7
• Net representation cost of 50
• Hospitalization insurance
• Car + unlimited fuel card OR home-work compensation
• 32 holidays
• End-of-year bonus
• Pension plan
• ECO vouchers
• Opportunities to follow trainings

Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you’ll feel comfortable in this company, who’s one of the biggest pharmaceutical companies in the world.

• 
  Technical Dossier analysis of feedback provided to Notified Bodies and Questions received from Notified Bodies.
• Assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution,
• Gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication,
• Assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests,
• Creates and approves ECO’s pertaining to the Coordinator’s projects and duties (including but not limited to SOPs, EU labeling approval),
• Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities,
• Responsible for compiling reports, presentations and creating flowcharts,
• Researches, collects, cross-check data from different sources, and responds to requests from internal colleagues,
• Responsible for communicating business related issues or opportunities to next management level,
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable,
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures,
• Performs other duties assigned as needed.