BE - Coordinator 2, Regulatory Compliance

Title: Regulatory Compliance Coordinator

Work location: Diegem

Introduction:

Do you have a passion for quality and gread computer and communication skills? Then this vacancy is perfect for you!

Job Summary:

Based in the European HQ in Belgium, the Regulatory Affairs Coordinator reports to the Regulatory Affairs Manager, Strategic Programs, EU MDR.

This position assists and supports the CSS Regulatory Affairs, Global Strategic Implementation Department in the execution of regulatory activities.

Duties & Responsibilities:

Under general supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate client, procedures and guidelines, this position:

• 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.

Experience and Education:

• A university, bachelor’s degree or equivalent
• 0-2 years of work experience, preferably but not limited to regulatory affairs

Required knowledge, Skills, Abilities, Certifications/Licenses and Affiliations:

• Analytical
• Good command of database and spreadsheet software
• Excellent written and verbal communication skills in English
• Creative and good computer skills: Excel, Power Point, One Note, Microsoft Team
• Attention to details
• Capacity to work independently and remotely
• Ability to take on diverse tasks, good organizational skills.