Regulatory Affairs Specialist

Nipro Europe Group Companies; Mechelen; Sur place; EUR 55 000 - 85 000; Plein temps

Résumé du poste

Nipro Europe Group Companies, based at the Mechelen, Belgium headquarters, is seeking a hands-on Regulatory Affairs Specialist for the RAQACA team. You will manage regulatory activities for medical devices and IVDs across Europe, Africa, India, and the Americas, coordinating registrations and lifecycle management with internal and external stakeholders.

The role emphasizes collaboration, regulatory intelligence, and process improvement to ensure timely authorizations and continued compliance.

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy or Regulatory Affairs.
• Experience in Regulatory Affairs within medical devices is preferred.
• Knowledge of medical device regulations and registration processes.
• Experience with regulatory submissions or lifecycle management across international markets.
• Strong project coordination and deadline management.

Responsabilités

• Coordinate national registration activities for MNE territories.
• Interact with internal/external stakeholders for registration dossiers and timelines.
• Maintain PVNC/VNC documents and certificates; update Belgian authorities.
• Provide regulatory intelligence and guidance to internal teams.
• Support continuous improvement of RA processes and cross-functional collaboration.

Connaissances

Regulatory affairs

Regulatory submissions

Lifecycle management

Project coordination

English proficiency

Formation

Bachelor's degree in Life Sciences / related field

Description du poste

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 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, we are looking for a Regulatory Affairs Specialist who is hands-on, and communicative to join us in our RAQACA team, based in our EMEA headquarters office in Mechelen, Belgium.

About the role

The Regulatory Affairs Specialist collaborates closely with internal and external stakeholders to ensure the successful market authorization and lifecycle management of medical devices and in vitro diagnostic devices within the Nipro Medical Europe territories.

• Drive and maintain market access by coordinating regulatory activities that support the timely authorization, registration, and continued compliance of medical devices and in vitro diagnostics across assigned territories.
• Partner with legal manufacturers and cross-functional stakeholders to evaluate, coordinate, and manage product changes throughout the product lifecycle, ensuring regulatory requirements are identified, communicated, and implemented effectively.
• Act as a trusted regulatory partner by providing accurate, timely, and actionable regulatory intelligence and guidance to internal teams, supporting informed business decisions and ensuring compliance within the countries under their responsibility.
• Contribute to a culture of continuous improvement and knowledge sharing by proactively identifying regulatory risks, opportunities, and process enhancements that strengthen organizational compliance and operational excellence.

How you will contribute

Registration/ RA Compliance (40%)

• Coordinate and plan national registration activities for MNE territories
• Coordinate and interact with Internal (Operations, Sales and Marketing) and External Stakeholders (Legal manufacturers, local distributors, Competent authorities) for the preparation of registration dossiers to meet the submission timelines
• Ensure appropriate follow-up of the registration projects and collect all the certificates (incl. those from the local distributors) and maintain documentation repository
• Ensure updates in Nipro Medical Europe activities (distributor, importer, exporter, and authorized representative) are reported to the Belgian Competent Authorities in due time
• 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
• Is the first point of contact for the Legal Manufacturers for the PVNC/VNC
• Internally follows-up on the timely approval/rejection by all involved internal stakeholders.
• Ensures to keep an overview of all related PVNC/VNC documents (incl. First lot information) and ensures the documents are timely stores.
• Is point of contact for the Regulatory review of Marketing Materials

Regulatory Intelligence (10%)

• Stay up to date with applicable regulations
• Interpret and communicate new or updated regulations to NME Regulatory Stakeholders
• Build relationships and network with relevant external

RAQACA Team member (15%)

• Contribute to the overall team and team activities
• Lead or be part of continuous improvement activities, including RA processes improvement
• Develop yourself and team members on RA content and the way of work
• Any ad-hoc activities to be discussed and agreed upon

What you bring to Nipro

Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or a related field.

Previous experience in Regulatory Affairs within the medical device industry.

Good understanding of medical device regulations and regulatory registration processes.

Experience working with regulatory submissions, product registrations or lifecycle management activities across international markets.

Strong project coordination skills with the ability to manage multiple priorities and meet deadlines.

Ability to collaborate effectively with a wide range of stakeholders, including manufacturers, distributors, commercial teams and regulatory authorities.

Fluency in English; additional European languages are considered an asset.

Comfortable working in an international and multicultural environment.

Strong analytical skills with the ability to interpret regulatory requirements and translate them into practical business actions.

Excellent communication and relationship-building skills, enabling you to influence and support stakeholders across different functions and cultures.

Proactive and solution-oriented mindset with a strong attention to detail and commitment to compliance.

Continuous learner who stays informed about regulatory developments and actively seeks opportunities for process improvement.

Why you should apply

Make a direct impact on patient access to healthcare

Gain broad international exposure

Be more than a document specialist as you will provide guidance to the business, supporting decisions and influencing product lifecycle activities

Work in a highly dynamic and evolving industry: The medical device and IVD regulatory landscape continues to evolve rapidly. You'll stay at the forefront of new regulations and contribute to ensuring compliance in a complex international environment

Contribute to continuous improvement: You'll have the opportunity to participate in and lead initiatives that improve regulatory processes, ways of working and compliance excellence across the organisation.

Take ownership of meaningful projects

Develop your career un Regulatory Affairs: The position offers exposure to registration activities, regulatory intelligence, lifecycle management, product changes and interactions with competent authorities, providing an excellent platform for long-term professional growth

NIPRO delivers on its purpose to help all people Live Longer. Live Better.

Our purpose is grounded in care, respect, and a deep commitment to the well-being of every life we touch—patients, partners, and team members. We believe that every colleague at NIPRO plays a vital role in our mission: to push innovation forward, improve patient outcomes, and make world-class healthcare accessible to all.

Respect is active and essential at NIPRO - it is our way of working, thinking, and growing together. We promote an environment where people feel safe to contribute, constructive ideas flow freely, and every person is treated with dignity.