Regulatory Affairs Manager

Join a leading Medical Device Manufacturer in expanding their Regulatory team. You would be joining an established team of 6 people. Working with life saving medical devices

Your main tasks

• Carrying out approvals for medical devices with authorities worldwide
• Creation and maintenance of registration documents
• Supervision of development projects regarding regulatory affairs
• Evaluation of amendments
• Negotiation of contracts with customers regarding RA aspects
• Advising and supporting clients on regulatory issues and drafting
• of the registration documents for medical devices and combination products
• Correspondence with authorities for inquiries and reports from authorities
• Assistance with customer and authority audits
• General QM tasks such as training, creation of Q documents, etc.

Your profile

• Technical basic training and/or a completed scientific degree
• 3 years of experience in regulatory affairs in the life sciences industry
• Experience working with Class IIb/III Medical Deices
• High quality awareness and pronounced personal responsibility
• Customer-oriented and communicative personality
• Stylish knowledge of German
• very good knowledge of English