Regulatory Affairs Specialist - Medical Devices - EN

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

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 the following profile:

• Bachelor's degree in Life Sciences, Biomedical Sciences, Pharmacy, Regulatory Affairs or related field
• 1-3 years of experience in Regulatory Affairs within medical devices
• Strong knowledge of MDR requirements and registration processes
• Experience supporting product registrations and lifecycle activities
• Excellent communication and stakeholder management skills
• Proactive personality who actively seeks information and drives actions forward
• Comfortable collaborating with international stakeholders
• Fluent in English
• Strong analytical and organizational skills
• Team-oriented with a continuous improvement mindset

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