Description : Registration Officer. Company : Nipro Europe Group Companies. Location : Mechelen

As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies is continuously committed to improving patient outcomes and quality of life. We are part of a large global network headed by Nipro Corporation Japan, an industry-leading healthcare company with over 35.000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical Europe, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.”

About the Role

The Registration officer is responsible for Market Authorization process of Medical Devices and In Vitro Diagnostics within Nipro Medical Europe Territories.

What You'll Do

• Manage and supervise registration dossiers by coordinating and interacting with internal stakeholders (Nipro Branches, legal manufacturers…).
• Register products with the Belgian Competent Authorities to meet the authorized representative and other NME’s EO obligations in the Medical Device Directive/Regulation.
• Collect Free Sales Certificates via the Belgian Competent Authorities which are required for registration dossiers
• Collaborating with Nipro Sales Subsidiaries and customers/distributors to present the documentation for the registration/Market Authorization dossier.
• Contributing to internal projects within various department where RA expertise would be required
• Keep track of the ever-changing legislation and local market access procedures in dedicated territories.
• Evaluate and coordinate changes proposed by legal manufacturers within Nipro Medical Europe
• Build relationships and network with relevant external stakeholders.
• You’ll perform all tasks in accordance with ISO and JSOX requirements and taking Nipro values into account.

What You'll Need

• A bachelor’s degree and at least 2 years of relevant experience in a medical devices company
• You are knowledgeable about medical regulation
• You enjoy administrative work
• You have an eye for detail and work accurately
• A positive spirit combined with great flexibility
• Teamspirit
• You enjoy a team culture where open communication and collaboration is highly valued
• Good knowledge of MS Office, especially Excel
• English is a must, every other language is a plus

What We’ll Offer

We will offer the right candidate the ability to develop and grow fast in an international business setting. Next to a competitive salary, you will land in a friendly and dynamic working environment where people enjoy autonomy and taking initiative. Together with you and the team we want to develop this working environment to a great place to work that further attracts talents around the globe.