RA Specialist - Great for development!

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.

Key Responsibilities :

Ensure compliance with relevant EU directives and global regulations for IVD products

Maintain and update technical documentation and Declarations of Conformity

Lead post-market surveillance activities and EUDAMED product registrations

Provide regulatory guidance to internal teams and external stakeholders

Monitor changes in WEEE, REACH, RoHS, and IVDR to ensure timely alignment

Support labeling and SDS documentation for hazardous materials

Review marketing, legal, and technical content for regulatory accuracy

Prepare for audits and inspections by maintaining thorough regulatory records

Your Profile :

Bachelor's degree (HBO level) in biology, chemistry, or a related technical / scientific field

Minimum 3 years of experience in the medical device or IVD sector

Hands-on experience with ISO 13485; knowledge of WEEE, REACH, and RoHS is a plus

Strong understanding of IVD registration and post-market requirements

Comfortable working across international teams-experience in pathology / lab systems is a bonus

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.