Regulatory Affairs - Environment

Nipro Europe Group Companies; Belgique; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Nipro Europe Group Companies seeks a Regulatory Affairs Specialist - Environment to ensure compliance of medical devices and packaging with environmental regulations across the EMEA. Based at our Mechelen, Belgium headquarters, you will lead regulatory intelligence and reporting, interfacing with EU authorities and internal teams.

You will develop processes, manage registrations, and support tender activities while collaborating with the RAQACA team to advance sustainability initiatives across

Qualifications

• Bachelor or Master in Regulatory Affairs, Environmental Sciences, or EU law.
• Solid knowledge of environmental regulations (REACH, CLP, WEEE, packaging, waste).
• Strong analytical and problem-solving skills.
• Ability to interpret complex legislation and communicate clearly.
• Experience in regulatory compliance and reporting.
• Excellent stakeholder management and collaboration skills.
• Organisational skills and attention to detail.
• Proactive, adaptable and team player.

Responsabilités

• Develop processes to ensure environmental compliance for products and distribution.
• Maintain data/files for audits and registrations.
• Liaise with internal stakeholders and European agencies.
• Collaborate with customers/distributors on environmental requests.
• Support tender teams with environmental compliance matters.
• Report regularly on compliance status to internal and external parties.

Connaissances

Regulatory affairs

Stakeholder management

Analytical skills

Problem-solving

Communication

Formation

Bachelor/Master in Regulatory Affairs

Environmental Science degree

EU law knowledge

Description du poste

As a total solution provider of medical devices and pharmaceutical packaging, Nipro Europe Group Companies (NEGC) 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 38,000 employees worldwide. Our European headquarters in Mechelen, Belgium covers a wide geographical reach (Europe, Africa, India, the Americas) and is home to Nipro Medical EMEA, Nipro PharmaPackaging International, and the Institute for Medical Practice (iMEP) Belgium.

For Nipro Medical EMEA (NME), we are looking for a Regulatory Affairs Specialist - Environment who is experienced, hands‑on, and communicative to join us in ourRAQACA team, based in our EMEA headquarters office in Mechelen, Belgium.

About the role

The Regulatory Affairs Specialist – Environment ensures the compliance of Nipro Medical Europe, its Branch organizations and the products placed on the market by this organization with environmental and sustainability related regulations. This entails Regulatory Intelligence for the EMEA market in the environmental regulatory domain, and operational support for reporting obligations and tender support.

How you will contribute

Operational Support Environment Regulations (40%)

• Develop processes to ensure compliance with environmental requirements (REACH, CLP, WEEE, ,...) for the distribution and import of medical devices and biocides manufactured by Nipro factories
• Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency or Nipro Corporation
• Act as a liaison between the internal stakeholders at NME, the manufacturer and European agencies to submit required registrations
• Collaborate with Nipro customers/distributors related to environmental requests
• Support internal tender teams concerning environmental compliance matters
• Regularly reporting on compliance status and measures to both internal and external parties

Regulatory Intelligence on environmental Legislation (30%)

• Maintain a thorough understanding of new and existing environmental regulations (Substances of Very High Concern, hazardous substances, eco-design, circular economy, packaging, waste) that may impact the organization’s products and processes
• Explaining regulations, procedures, and policies to all employees and stakeholders as necessary
• Serve as contact point for EU environmental regulatory compliance

Building and Maintaining Knowledge Network within Nipro and with other stakeholders (10%)

• Engaging with EU institutions and authorities for the interest of the mother company Nipro Corporation.
• Attend task force meetings, working groups and/or events of European organizations on environmental related legislation with the aim to elevate emerging regulatory requirements to the mother company Nipro Corporation
• Collaborate with NME HQ, Branches and factories on Environmental topics, e.g. ISO14001, Ecovadis
• Collaborate within NEGC ESG team

(Pro-)Active Participation as RAQACA team member (20%)

• Contribute to internal projects (e.g. Team Objectives) and activities (e.g. impact assessment of product changes on environmental compliance) of own and other departments
• Collaborate with other team members to secure functioning of the RAQACA team

What you bring to Nipro

• Bachelor or Master Degree in Regulatory Affairs, Environemental Siences, Life Engineering, Engineering, EU Laws,...
• Knowledge of environmental and sustainability regulations (REACH, CLP, WEEE, pakaging, waste management, circular economy and EU sustainability legislation)
• Strong analytical and problem‑solving skills.
• Ability to interpret complex legislation and communicate it clearly.
• Experience in regulatory compliance and reporting.
• Excellent stakeholder management and collaboration skills.
• Strong organisational skills and attention to detail.
• Proactive, adaptable and eager to learn.
• Team player with a hands‑on mindset.

Why you should apply

• Make a real impact by helping shape Nipro's environmental compliance and sustainability journey across the EMEA region.
• Work at the forefront of evolving environmental and regulatory legislation, influencing how medical devices reach the market.
• Collaborate with international colleagues, manufacturing sites, European authorities and industry stakeholders.
• Gain exposure to a broad range of topics, including environmental compliance, ESG initiatives, sustainability reporting and regulatory intelligence.
• Be part of a purpose‑driven company that improves patient outcomes through innovative healthcare solutions.
• Enjoy a collaborative and supportive international work environment where your expertise and ideas are valued.