Regulatory Affairs Specialist
Freelance Regulatory Affairs Specialist (m/w/d) | Medical Devices | Global Regulatory Impact
Shape the Future of Healthcare Innovation
Join a leading international medical technology environment and play a pivotal role in ensuring innovative healthcare products reach patients around the world. This position offers the opportunity to influence both new product development and lifecycle management while navigating complex global regulatory frameworks.
As a Regulatory Affairs Specialist, you will act as a trusted regulatory partner across Engineering, Quality, R&D, Manufacturing, and Supply Chain teams. Your expertise will directly contribute to maintaining global market access, supporting innovation, and ensuring ongoing compliance in highly regulated international markets.
Key Responsibilities
- Support product development and lifecycle projects from a regulatory perspective
- Ensure compliance with applicable regulatory requirements across global markets
- Review, compile, and maintain technical documentation for product registrations
- Coordinate and support FDA 510(k) submissions and Letters-to-File
- Support EU MDR/MDD compliance and remediation activities
- Manage regulatory deliverables, timelines, and stakeholder communication
- Participate in Engineering Change Boards and assess regulatory impact of design and supply chain changes
- Contribute to CAPA, risk management, and change control activities
- Maintain regulatory data and documentation systems
Required Experience & Skills
- Several years of Regulatory Affairs experience within the medical device industry
- Solid experience with FDA regulations and 510(k) submissions
- Experience supporting global product registrations and technical documentation
- Strong knowledge of EU MDR and/or MDD requirements
- Experience working within highly regulated environments
- Excellent stakeholder management and communication skills
- Fluent English; German is advantageous
📍 Location: Germany-based candidates only
🏠 Working Model: 100% remote possible after onboarding
🕒 Start Date: September 2026
📅 Contract Duration: Until March 31, 2027
✅ Full-time preferred