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

Start Date: October 2026

Duration: 9 months (extension possible)

Workload: 80–100% (32–40 hours/week)

Project Description

For an international medical device manufacturer, we are looking for an experienced Regulatory Affairs Consultant to support the global Regulatory Affairs team with international product registrations and regulatory compliance activities across multiple markets.

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.