Regulatory Affairs Assistant (6 months)

GC Corporation was founded in 1921 in Japan and has developed itself into one of the most prominent companies in the development, production and distribution of a very wide range of dental products. Since 1972 GC Europe NV, our European Headquarter is located at the Researchpark Haasrode in Leuven (Belgium). GC Europe NV supports and leads our different sales offices and dealers. Our warehouse spreads our products to Europe and the Middle East.

We are currently looking for a:

Regulatory Affairs Assistant (6 months)

Your Mission

• Ensuring that the organization at all times meets its legal obligations with regard to:
  • Product authorization in countries for which GC Europe is responsible.
• Responsible for product- related information that is legally required to support the activities of the organization.
• Expanding “center of excellence” with regard to product authorizations, where the expertise is not only used to ensure compliance, but also to anticipate trends/changes.
• All this in line with the policy of GC Europe.

Main responsibilities:

• Support the product authorization process in targeted non‑EU countries by collecting, organizing, and preparing administrative documentation required for submissions, in collaboration with the Regulatory Team and other internal stakeholders.
• Support the legalization of documents required by local authorities to ensure timely and compliant processing.
• Maintain and update regulatory documentation, ensuring that certificates, declarations, CE‑marking documents are complete and properly archived.
• Assist in assembling product technical files and other regulatory documents by gathering input from internal departments.
• Coordinate with the Sales Department and local agencies to obtain countries-specific requirements and support the execution of registration activities in selected markets.
• Ensure availability and proper handling of mandatory legal and regulatory information, maintain confidentiality and compliance with internal procedures.

Requirements:

• Preferable bachelor or master’s degrees in Regulatory, Public Health, Politics, Business and Economics, Life or Clinical sciences
• Previous experience in administrative roles within Medical Device, Pharma, Life Science, or similar regulated industries is an advantage.
• Basic understanding of regulatory or quality documentation processes is desirable, though not mandatory.
• Fluency in using IT systems, like Web based/MS Office applications, ERPs
• Process and policy oriented, analytical thinking, able to manage policies, procedures and databases
• Customer focus, self-determination, autonomous and self-supporting
• High flexibility and resilience in adapting to a fast pacing regulatory environment
• Excellent command of both...