Consultant Regulatory Affairs- International Registration (m/f/d)

Project Description

Key Responsibilities

• Develop and execute regulatory strategies for international product registrations.
• Coordinate and manage medical device registrations with international distributors, affiliates, and regulatory authorities.
• Prepare, compile, and maintain regulatory documentation required for international submissions.
• Prepare and support FDA submissions (e.g. 510(k)) as well as registrations for other international markets.
• Monitor submission timelines, registration deadlines, and renewal activities.
• Assess and manage regulatory change notifications and product modifications.
• Ensure compliance with applicable regulatory requirements, including EU MDR, FDA regulations, and other international standards.
• Collaborate closely with cross-functional teams including R&D, Quality Assurance, Product Management, and international stakeholders.

Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a comparable discipline.
• Several years of experience in Regulatory Affairs within the medical device industry.
• Proven experience with international product registrations.
• Strong knowledge of FDA regulations, including hands-on experience preparing or supporting 510(k) submissions.
• Good understanding of EU MDR and global regulatory requirements.
• Experience interacting with regulatory authorities and Notified Bodies is highly desirable.
• Fluent in German and English, both written and spoken.