Person Responsible for Regulatory Compliance (PRRC)

Our client, a leading medical device and diagnostic distributor in the Benelux, is looking for a PRRC to play a pivotal role in making high-quality medical devices and in-vitro diagnostics available to hospitals, laboratories, and healthcare professionals. You will work from the HQ and report directly to General Management, giving you a decisive voice in how processes are designed, which priorities are set, and how the quality management system evolves.

This role is also available for 80% part-time, which will improve your work-life balance!

Benefits

• End-to-end regulatory ownership: Shape and manage the full compliance landscape for distributor/importer activities, rather than focusing on one narrow subdomain.
• High visibility and direct influence: Report to the management team, act as trusted advisor in business-critical decisions, and co-drive the development of the quality management system in a growing organization.
• Broad product portfolio with qualitative brands: Your work remains varied and technically interesting, with exposure to different regulatory challenges.

Role Responsibilities

• Ensure MDR/IVDR compliance across the Benelux by overseeing conformity assessment, technical documentation, post‑market surveillance, vigilance reporting, and FSCA coordination, directly contributing to patient safety and uninterrupted market access.
• Develop, implement, and maintain procedures for distributor/importer roles (Article 14 MDR/IVDR, traceability, EUDAMED, national registrations), embedding them in a robust and scalable quality management system aligned with company growth and strategy.
• Act as official regulatory liaison and regulatory change leader by representing the company towards authorities such as the FAGG, steering incident and complaint management, and leading implementation of new frameworks such as the PPWR, including correct labeling and multilingual translations (NL/FR/DE).

Requirements

• Master's or Bachelor's degree in Biomedical Sciences, Pharmacy, (Bio)Engineering or Law
• Several years of experience in Regulatory Affairs and/or Quality Assurance within medical devices or IVD
• Proven MDR/IVDR and QMS expertise
• Fluency in Dutch and English

If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Consulting website or on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

Do you have any disability or condition that could affect you in the application and interview process? Please feel free to share this information as part of your application, including any necessary adjustments you might need, so we can help make the process easier for you. We assure you this information will not have any negative effect on the interview process outcome.

About NonStop: We are NonStop, a leading provider of staffing solutions throughout Europe and now also in the US. We're passionate about connecting talent with opportunity and work non-stop to support our clients in hiring the best talent for their teams. Feel free to pop over to our website, NonStop Consulting ( for more information, to browse all our roles, or to let us know how we can help you.

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