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  • 1 month ago

jobs description

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 RA Specialist Custom Solutions (CS) is responsible for Market Authorization process of Medical Devices and In Vitro Diagnostics within EMEA (and beyond on exceptional basis.)
• *What You'll Do**:

- Manage and supervise registration dossiers by coordinating and interacting with internal stakeholders (Nipro Branches, legal manufacturers, customers ).
- Liaising registrations between Custom... Solution customers and legal manufacturers
- Closely cooperating with sales dept. for regulatory changes that are impacting CS customers
- Coordinate, plan and interact with relevant internal and external stakeholders
- Review of agreements for CS customers
- For the dedicated territories, exhibit a good understanding on the in-countries regulations and guidelines to ensure that all regulatory aspects are closely monitored and fulfilled (or work with local expert in case of complex national requirements).
- Keep track of local registration requirements and timelines.
- Build relationships and network with relevant external stakeholders
- Contributing to internal projects within various department where RA expertise would be required
- 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.
- Provide RA support for registration to Nipro Packaging International (NPI).
• *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
- You enjoy working in a team and perform at your best in 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
Mechelen Belgium


Apply - Regulatory Affairs Specialist Mechelen