MAIN TASKS
Performing and monitoring of medical device registration with prime focus in the EU Market; lifecycle management activities for devices of risk Class I-III from regulatory perspective. Additionally, creating and maintaining Technical Documentation for class I - III devices.
MAIN TASKS
* Implementing and ensuring compliance with current regulatory requirements between cross functions.
* Performing gap analysis on any new applicable regulatory requirements.
* Coordinating communication between Regulatory Affairs and Development plus Product Management departments.
* Supporting Q&R - activities related to QMS requirements (e.g. review of design documents within the design control process)
* Coordinating Clinical evaluation activities would be an advantage
YOUR COMPETENCIES
* 3-5 years of professional experience in a similar position in Regulatory Affairs.
* Bachelor/Master/PhD degree in natural sciences or engineering. Ideally with knowledge of tumor therapy, oncology.
* Working experience with MDD 93/42/EEC, EN ISO13485:2016, EN ISO14971.
* Very good knowledge of MDR 2017/745.
* Knowledge of MEDDEV 2.7/1 rev.4 would be an advantage.
* Excellent written & verbal command of German (minimum C1/C2) & English.
* Very good Microsoft Office skills.
* Analytical thinking, structured and independent way of working will round up the perfect candidate.
