Make a Real Impact in Medical Devices as a Regulatory Specialist

Department: Quality Assurance & Regulatory Affairs
Reports to: Regulatory Affairs Manager
Location: Partizanske

About us

Medline is a leading provider of medical-surgical products and supply chain solutions, serving all points of care. Through a wide-ranging product portfolio, a robust supply chain network and modern clinical solutions, Medline helps healthcare providers (HCPs) improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, United States, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories. Outside the US, Medline International B.V. serves as the international headquarters and is located in the Netherlands (currently Arnhem; to be moved to Utrecht in 2025). To learn more about Medline’s operations in Europe, visit www.medline.eu.

Purpose

As a Regulatory Specialist, you will ensure that all medical devices comply with both international and local regulatory requirements. You will be responsible for preparing and maintaining technical documentation, supporting product certification processes, and carrying out post‑market surveillance activities to uphold the highest regulatory standards.

How can you help us?

Regulatory & Compliance:

• Drive regulatory strategy for assigned products and ensure compliance with EU MDR, ISO 13485, and global regulations.

• Turn regulatory requirements into clear internal processes and documentation standards.

• Identify risks early and suggest practical mitigation steps.

• Serve as the main regulatory contact for distributors, partners, and competent authorities.

Post‑Market Surveillance

• Lead PMS activities and ensure imported/distributed products meet local requirements.

• Manage distributors and support audits to maintain market compliance.

Technical Documentation

• Prepare and maintain essential regulatory documentation (STED, PMS reports, risk files).

Cross‑Functional Collaboration

• Partner with R&D, Quality, Supply Chain, Marketing, and Operations across the product lifecycle.

• Provide regulatory guidance for product changes, new launches, and market expansions.

• Align regulatory activities with global teams and regional distributors.

Additional Ways You’ll Contribute

Product Registrations & Certifications

• Support CE marking, ISO audits, and registrations with competent authorities.

Regulatory Intelligence

• Monitor global regulatory changes and update internal processes proactively.

• Drive improvements that simplify and strengthen regulatory workflows.

Documentation & Data Management

• Maintain supplier records and the regulatory product database.

Audits & Inspections

• Contribute to internal, notified body, and authority audits, including documentation and corrective actions.

Market & Industry Awareness

• Track industry trends and share relevant insights with internal teams.

Are you a match?

• University Degree in Sciences or Engineering specialized in Regulatory Affairs

• Good written and oral communication in English.  

• Positive attitude, results oriented

• Leadership experience

• Good knowledge of continuous improvement tools – Greenbelt/5S  

What we offer

• Annual bonus of 7% of gross annual salary, paid twice a year based on KPI performance

• Transportation allowance

• Seniority bonus

• Meal allowance in the cafeteria

• Financial reward for improvement suggestions

Ready for a new challenge?

Medline thrives when everyone feels truly connected and empowered to contribute their unique insights. We aim to ensure an environment where every individual feels a strong sense of belonging and is fully engaged. We're eager to welcome applicants, regardless of background and/or lived experiences, recognizing that our differences in perspectives enables us to carry out our mission to help improve healthcare delivery and outcomes. We look forward to receiving your application.

Contact

Please apply below with your CV or LinkedIn profile before 15.02.2026. We look forward hearing from you!

Medline is committed to reducing its carbon footprint, developing responsible products, supporting its employees and local communities, and promoting high ethical standards both internally and among our supply partners. Click here to learn what Medline is doing to make healthcare more sustainable for people and the planet.