Regulatory Affairs Specialist (m/f/d) MedTech

PreciPoint GmbH, located in Garching near Munich,?develops intelligent microscope systems and innovative analysis software, thus contributing to the digitalisation and further development of laboratories. Our customers range from medical laboratories and research institutions to industry. 

To support our team of experts, we are looking for a Regulatory Affairs Specialist (m/f/d) MedTech on a permanent basis. 

• Ensuring compliance with all relevant local, national, and international regulatory requirements, in particular IVDR and FDA regulations 

• Contributing to the development and implementation of regulatory strategies for product development and market introduction 

• Close and proactive collaboration with cross-functional development teams to ensure complete and accurate technical documentation 

• Creating and maintaining technical documentation in accordance with country-specific regulations 

• Taking responsibility for handling deviations and corrective actions within the CAPA process 

• Developing quality assurance measures to monitor and ensure compliance with product requirements in manufacturing processes 

• Supporting and actively contributing to quality management topics 

• Three years of professional experience in regulatory affairs or quality management 

• In-depth knowledge of the EU Regulation 2017/746 (IVDR) and FDA requirements 

• Bachelor’s or master’s degree in medical technology, mechanical engineering, product management, or related field 

• Fluent English and good German language skills 

• Independent, accurate, and structured work style 

• Analytical and creative approach to quickly identifying and solving problems 

• Tailor-made introduction program and numerous continuing education programs 

• A multicultural team with more than 10 different nationalities 

• Flexible working hours in a modern and digital company 

• An attractive workplace in the Business Campus Garching with benefits such as a subsidised canteen, fitness and shopping facilities, underground railway within 5 minutes walking distance, parking card 

• An open, positive, and constructive feedback culture where feedback is given both ways 

• Free drinks and healthy snacks 

• Corporate benefits with well-known partners 

• Regular team building activities 
  
  Join PreciPoint and make a positive impact on the future of our health system!