Regulatory Affairs Manager (m/f/d)

Your Responsibilities

• Develop the U.S. regulatory strategy and oversee its implementation across product projects.
• Prepare and support FDA submissions, particularly 510(k) applications and pre-submission inquiries.
• Coordinate communication with the FDA and our U.S. partners and serve as the primary point of contact.
• Resolve regulatory issues in collaboration with R&D, Quality Management, and Product Management, and involve external service providers and testing laboratories.
• Ensure that development projects and technical documentation comply with relevant FDA requirements.
• Provide regulatory support for testing, verification, and validation, and assess the impact of product changes on approvals and compliance.
• Further develop the quality management system in accordance with FDA QMSR and 21 CFR Part 820, and prepare MEDTRON for FDA inspections.
• Identify nonconformities and regulatory action items, initiate improvements, and systematically expand the company’s FDA expertise.

Your Profile

• You have several years of professional experience in regulatory affairs for medical devices—ideally at least five years.
• You are familiar with FDA requirements for medical devices from practical application.
• You have previously supported 510(k) submissions; experience with pre-submissions and direct communication with the FDA is particularly welcome.
• You are very familiar with the FDA QMSR, 21 CFR Part 820, and ISO 13485.
• You are familiar with relevant standards such as ISO 14971, IEC 62304, IEC 62366, and IEC 60601.
• Experience with active medical devices—such as infusion pumps, injectors, or similar systems—is a plus.
• You have managed and collaborated with external testing laboratories, development service providers, or regulatory consultants.
• You hold a degree in medical technology, engineering, or the natural sciences, or a comparable qualification. Above all, your practical FDA experience is crucial to us.
• You are fluent in English and willing to travel to the U.S. occasionally.