Regulatory Affairs Manager (897214-AS)

Our customer is a global company with a pioneering role in the research and development of endoscopes, medical instruments and devices for sale. As a system provider, the company combines its expertise in endoscopy with software solutions for integration in the operating room and for supporting clinical process and resource management.

We are currently looking for an enthusiastic Regulatory Affairs Manager for a permanent position in Germany.

If you are interested, kindly  send us a English version of your CV.

Main Responsibilities:

• Support and coordination in the creation of technical documentation for assigned medical device groups
• Support of development projects
• Identify the worldwide regulatory requirements for assigned medical device groups
• Development of testing and approval strategies for worldwide sales
• Analyze and optimize procedures and processes
• Monitoring of normative requirements in the development process
• Close cooperation with the development teams and other departments
• Targeted training for development in relation to normative aspects

Qualifications and Experience:

• Completed scientific / technical degree
• Minimum 5 years of experience within regulatory affairs function on EU/global level
• Experience within medical devices/diagnostics is highly desirable
• Knowledge of the relevant product standards (IEC 60601-1, IEC 62304, IEC 14971, etc.)
• Expertise in the field of medical-technical products is desirable
• Confident appearance in global project structures
• Communicative and analytical skills
• Independent and structured way of working
• Fluent in English (written and spoken)