Regulatory Affairs Specialist

NIPRO Corporation - Global; Antwerpen; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

NIPRO Corporation - Global is seeking a Regulatory Affairs Specialist to drive market access and lifecycle management for medical devices across Europe. You will coordinate national registrations, interact with legal manufacturers and authorities, and provide regulatory guidance for product changes and marketing materials.

You will stay current with evolving regulations, share intelligence with stakeholders, and contribute to continuous RA process improvements in a multicultural, international

Qualifications

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or related field.
• 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 across international markets.
• Strong project coordination skills with the ability to manage multiple priorities and meet deadlines.

Responsabilités

• Coordinate and plan national registration activities for MNE territories.
• Coordinate and interact with internal and external stakeholders for preparation of registration dossiers.
• Ensure follow-up of registration projects and maintain documentation repository.
• Register products with Belgian authorities to meet EO obligations.
• Provide regulatory guidance for marketing materials and product changes.
• Stay up to date with applicable regulations and communicate updates to stakeholders.
• Contribute to RA team initiatives and process improvements.

Connaissances

Regulatory affairs

Project coordination

Stakeholder management

Regulatory intelligence

Cross-functional collaboration

English fluency

Formation

Bachelor's degree in Life Sciences

Regulatory affairs related degree

Description du poste

About the Company

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.

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.

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.

Product Changes, Claims, Marketing Materials (15%)

• Act as the first point of contact for the Legal Manufacturers for the PVNC/VNC.
• Internally follow up on the timely approval/rejection by all involved internal stakeholders.
• Ensure an overview of all related PVNC/VNC documents (incl. first lot information) and ensure the documents are timely stored.
• Act as 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 stakeholders.

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.
• Perform 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.
• Contribute to continuous improvement; you will have the opportunity to participate in and lead initiatives that improve regulatory processes, ways of working and compliance excellence across the organisation.
• Join a global healthcare company.
• Take ownership of meaningful projects.
• Develop your career in 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.