Post Market Surveillance Manager - Part-time (m/f/d)

HUMAN offers safe laboratory diagnostics in more than 160 countries. How do we do that? With reliable reagents and analysis systems as well as employees who live customer orientation and contribute to improving global health care. Look forward to a medium-sized company where you can fill free spaces with a sense of decision. At the next time we are looking for Account Manager (m/w/d)

• limited to 2 years / 20 hours weekly - Location Wiesbaden To strengthen our team in the field of Clinical Affairs & Risk Management, we are looking for a dedicated personality as a post-market villance manager (m/w/d). In this responsible role, you contribute significantly to the safety, performance and regulatory compliance of our IVD products and actively shape our PMS processes under Regulation (EU) 2017/746.

Responsible control and coordination of all Post-Market-Surveillance (PMS) activities in the field of Clinical Affairs & Risk Management Systematic collection, evaluation and interpretation of PMS-relevant data (e.g. complaints, sales figures, PMPF data) Creation and maintenance of regulatory conformer PMS plans and reports Close cooperation with internal interfaces in the regulated IVD environment Support for risk management in accordance with ISO 14971 Development and optimization of existing processes in a growing regulatory environment

Completed scientific studies (optional doctoral studies) or technical training (e.g. MTA, BTA) with relevant professional experience At least 2-3 years of professional experience in the IVD or medical device environment Very good Excel knowledge Experience in the evaluation and evaluation of laboratory results of advantage Knowledge of IVD Regulation (EU) 2017/746, as well as knowledge of ISO 13485, ISO 9001 and ISO 14971 standards Very good knowledge of German and English Self-employed, structured and reliable operation Commitment, initiative and strong communication skills

A varied and exciting working environment with a lot of design space Collegial team, short decision-making, a personal relationship Employer-funded private health insurance Flexible working hours and home office by arrangement up to 50% Canteen and free fruit and drinks Further training Free parking in the house