Regulatory Affairs Manager (m/f/d)

As a true German manufacturer of single-use medical instruments, ensuring compliance with the highest international standards is the bedrock of our business. We are seeking a dedicated and detail-oriented Regulatory Affairs Manager to join our team and take ownership of our quality management and product registration processes. This is a critical role for safeguarding our commitment to quality and enabling our international growth.

Your Responsibilities

• Maintaining and optimizing our Quality Management System according to ISO 13485 and MDR (EU 2017/745).
• Creating, updating, and managing the complete technical documentation for our medical devices.
• Planning and executing international product registrations and approvals.
• Acting as the primary contact for regulatory authorities, notified bodies, and international partners.
• Conducting risk management activities according to ISO 14971 and implementing post-market surveillance (PMS) plans.
• Organizing and leading internal and external audits.

Your Profile

• A university degree in medical technology, engineering, natural sciences, or a related field.
• Proven professional experience in the regulatory affairs of medical devices, particularly with Class I sterile products.
• In-depth knowledge of relevant standards and regulations, especially MDR (EU 2017/745) and ISO 13485.
• Structured, independent, and precise working style with a high sense of responsibility.
• Excellent communication skills; fluent in both German and English.