
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
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Ensure regulatory compliance and product certifications within the EMEAI region
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Maintain up-to-date technical documentation and EU Declarations of Conformity
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Oversee and execute post-market surveillance activities
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Support internal and external stakeholders with regulatory, quality, and certification queries
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Initiate and maintain product registrations in the EUDAMED database
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Monitor and report on compliance status and improvements
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Ensure adherence to relevant EU directives including WEEE, REACH, and RoHS
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Review marketing, legal, and technical documentation for regulatory alignment
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Provide regulatory guidance for product development and cross-functional teams
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Advise on labeling requirements and Safety Data Sheets (SDS) for hazardous materials
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Monitor evolving international regulations impacting products and processes
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Collaborate closely with global regulatory counterparts across regional sites
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Maintain accurate records for audits and regulatory inspections
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Contribute to personal and departmental performance goals
Your Profile
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Bachelor’s degree (HBO level) in a relevant scientific or technical field (e.g., biology, chemistry, product safety)
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Minimum of 3 years’ experience in the medical device industry
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Familiarity with IVD products and their registration requirements
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Solid understanding of ISO 13485, with additional experience in WEEE, REACH, and RoHS considered a plus
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Strong international background, preferably with exposure to pathology or laboratory systems
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Fluent in English, both written and spoken
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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.