NonStop Consulting

Regulatory Affairs Specialist – Leiden Region (The Netherlands)
IVD | ISO 13485 | EU Regulations | Global Compliance

A dynamic and internationally active organization in the Leiden region is looking for a Regulatory Affairs Specialist to support its regulatory strategy across the EMEAI region. In this role, you’ll ensure compliance with relevant directives and support both product and process certification for a broad portfolio of in-vitro diagnostic (IVD) solutions.

You will act as a key point of contact for regulatory bodies and internal stakeholders, and serve as the Person Responsible for Regulatory Compliance (PRRC) as outlined in the IVDR (EU) 2017/746, Article 15.


Key Responsibilities

  • Ensure regulatory compliance and product certifications within the EMEAI region

  • Maintain up-to-date technical documentation and EU Declarations of Conformity

  • Oversee and execute post-market surveillance activities

  • Support internal and external stakeholders with regulatory, quality, and certification queries

  • Initiate and maintain product registrations in the EUDAMED database

  • Monitor and report on compliance status and improvements

  • Ensure adherence to relevant EU directives including WEEE, REACH, and RoHS

  • Review marketing, legal, and technical documentation for regulatory alignment

  • Provide regulatory guidance for product development and cross-functional teams

  • Advise on labeling requirements and Safety Data Sheets (SDS) for hazardous materials

  • Monitor evolving international regulations impacting products and processes

  • Collaborate closely with global regulatory counterparts across regional sites

  • Maintain accurate records for audits and regulatory inspections

  • Contribute to personal and departmental performance goals


Your Profile

  • Bachelor’s degree (HBO level) in a relevant scientific or technical field (e.g., biology, chemistry, product safety)

  • Minimum of 3 years’ experience in the medical device industry

  • Familiarity with IVD products and their registration requirements

  • Solid understanding of ISO 13485, with additional experience in WEEE, REACH, and RoHS considered a plus

  • Strong international background, preferably with exposure to pathology or laboratory systems

  • Fluent in English, both written and spoken

  • Strong communication skills and ability to work cross-functionally


This is a unique opportunity to take on a central regulatory role in a fast-paced, innovative, and quality-driven environment. If you’re passionate about ensuring compliance and driving product excellence in the IVD space, we’d love to hear from you.

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