Regulatory Affairs Specialist - Medical Devices - EN

Over deze functie

International healthcare organization active in the medical device sector, supporting patient care through innovative products distributed across multiple global markets.

Jobomschrijving

As a successful **Regulatory Affairs Specialist - Medical Devices - EN**, you will have the following responsibilities:

* Coordinate product registrations across assigned international markets
* Prepare and submit regulatory documentation with internal and external stakeholders
* Support ongoing compliance activities for medical device portfolios
* Manage regulatory aspects of product changes throughout the lifecycle
* Review and assess regulatory implications of marketing materials
* Monitor regulatory developments and communicate relevant updates
* Act as a key contact for manufacturers, distributors, and authorities
* Contribute to continuous improvement initiatives within Regulatory Affairs

As a successful **Regulatory Affairs Specialist - Medical Devices - EN**, you will have:

* Competitive salary package including extra-legal benefits
* Hybrid working model
* International exposure within a global healthcare environment
* Strong onboarding and development opportunities
* Collaborative culture with close interaction between Regulatory Affairs, Quality, and Clinical teams
* Opportunity to build a long-term career in Regulatory Affairs