Regulatory Affairs Specialist

K-Recruiting Life Sciences; Germany (OH); On-site; USD 96,000 - 191,000; Part time

Job summary

Freelance Regulatory Affairs Specialist (m/w/d) in Medical Devices is sought to navigate global regulatory frameworks and influence development and lifecycle management. You will partner with Engineering, Quality, R&D, Manufacturing, and Supply Chain to maintain market access and compliance across international markets.

Role emphasizes cross-functional collaboration, experience with FDA 510(k), EU MDR/MDD, and robust technical documentation.

Qualifications

• 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.

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

Skills

Regulatory Affairs

510(k) submissions

EU MDR/MDD

Medical devices

Stakeholder mgmt

Technical documentation

Job description

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

Contract Duration: Until March 31, 2027