Regulatory Affairs Specialist

Il y a 6 mois


Mechelen, Belgique Nipro Europe Group Companies Temps plein

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.”

In this context we are looking for a **temporary RA Specialist Environment** to support our company during 8 months (replacement during maternity leave).

**About the Role**:
The Regulatory Affairs Specialist Environment follows-up on EU environmental laws and policies and ensures compliance of Nipro Medical EMEA with relevant environmental legislation.

**What You'll Do**:

- Lead the implementation of ISO 14001 (Environmental Management System standard) in Nipro Medical Europe NV, with the support of colleagues from the Quality Team
- Maintain a thorough understanding of new and existing European environmental and chemicals regulations (hazardous substances in products, packaging, circular economy, waste) that impact the organization’s products and processes
- Develop processes to ensure Nipro Medical Europe NV’s compliance with European environmental laws
- Engage with EU institutions and authorities for the interest of the mother company Nipro Corporation
- Collaborate with Nipro customers/distributors to respond to environmental requests and requirements
- Support EU Nipro branches with the fulfilment of European environmental requirements and, upon request and to the extent possible, of national requirements
- The employee performs all tasks in accordance with ISO quality and JSOX requirements, whilst always taking Nipro values into account

**What You'll Need**:

- You hold a Masters degree in a scientific or legal background
- Project management skills
- Experience with a hands on implementation of ISO 14001
- Familiar with the following legislations: REACH, SCIP, CLP, WEEE, Battery Regulation and upcoming packaging regulation
- Excellent command in English is required, additional languages are a plus

**What We’ll Offer**:



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