NonStop Consulting
- Location:
- Leiden – Zuid-Holland, Nederland, Netherlands
- Salary:
- Negotiable
- Type:
- Permanent
- Main Industry:
- Search Health, Nursing & Social Services Jobs
- Advertiser:
- NonStop Consulting
- Job ID:
- 132044364
- Posted On:
- 30 June 2025
Regulatory Affairs Specialist – Leiden Area, The Netherlands
IVD | ISO 13485 | EU/Global Compliance | PRRC
An innovative and globally active company in the Leiden area is looking for a Regulatory Affairs Specialist to strengthen its compliance and certification activities across the EMEAI region. In this key role, you’ll support regulatory strategy, maintain certifications, and ensure that a diverse portfolio of in-vitro diagnostic (IVD) products meets evolving international standards.
As the designated Person Responsible for Regulatory Compliance (PRRC) under IVDR (EU) 2017/746, Article 15, you’ll serve as a vital link between regulatory bodies and internal teams, helping to shape product development, documentation, and market readiness.
x1F527; Key Responsibilities:
Ensure compliance with relevant EU directives and global regulations for IVD products
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Maintain and update technical documentation and Declarations of Conformity
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Lead post-market surveillance activities and EUDAMED product registrations
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Provide regulatory guidance to internal teams and external stakeholders
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Monitor changes in WEEE, REACH, RoHS, and IVDR to ensure timely alignment
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Support labeling and SDS documentation for hazardous materials
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Review marketing, legal, and technical content for regulatory accuracy
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Prepare for audits and inspections by maintaining thorough regulatory records
x2705; Your Profile:
Bachelor’s degree (HBO level) in biology, chemistry, or a related technical/scientific field
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Minimum 3 years of experience in the medical device or IVD sector
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Hands-on experience with ISO 13485; knowledge of WEEE, REACH, and RoHS is a plus
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Strong understanding of IVD registration and post-market requirements
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Comfortable working across international teams-experience in pathology/lab systems is a bonus
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Fluent in English with strong interpersonal and cross-functional communication skills
This is a fantastic opportunity to take ownership of regulatory activities in a collaborative, quality-focused environment. If you’re eager to contribute to innovative healthcare solutions and ensure top-tier compliance, we’d love to connect with you.
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