Medical Device Technical Expert - Risk Management (m/f)

REFERENZNUMMER:

297037/11

IHRE AUFGABEN:

-Author of the documentation in the medical device risk management file
-Ensure timely completion and quality of the assigned risk management files
-Lead specific risk management activities within projects, as agreed with project leaders
-Manage the overall risk management program of the packaging and device development activities within the team
-Ensure compliance with ISO 14971 in all development projects under responsibility of TRD/parenteral
-Supervise risk management activities in all development projects under responsibility of TRD/parenteral
-Ensure compliance with regulatory and normative guidelines, focusing on medical device risk management
-Shape and improve the current internal risk management process for medical devices
-Guide internal and external functions on creating, reviewing and approving medical device risk management files
-Apply FDA CFR 820, ISO13485 and ISO 14971 risk management in assigned projects

IHRE QUALIFIKATIONEN:

-Pharmaceutical education, Master or PhD
-Experience in risk management of the packaging and device development
-Experience in technical research and development issues
-Profound knowledge of quality system regulations (FDA CFR 820, ISO13485 and of ISO14971 risk management
-Fluency in English, German skills are beneficial

WEITERE QUALIFIKATIONEN:

Quality manager, R&D scientist