Regulatory Affairs Specialist (m/f/d) MedTech

Regulatory Affairs Specialist (m/f/d) MedTech

PreciPoint GmbH,locatedinGarchingnear Munich,?develops intelligent microscope systems and innovative analysis software, thus contributing to thedigitalisationand 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 aRegulatory Affairs Specialist (m/f/d) MedTech on a permanent basis.

Your profile

• Three years of professional experience in regulatory affairs or quality management
• In-depth knowledge of the EU Regulation2017/746(IVDR) and FDA requirements
• Bachelor’s or master’sdegree in medical technology, mechanical engineering, product management, or relatedfield
• Fluent English and good German language skills
• Independent, accurate, and structured work style
• Analytical and creative approach to quickly identifying and solving problems

Your tasks

• 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

What we offer

• 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
• Freedrinksandhealthysnacks
• Corporate benefits with well–known partners
• Regular team building activities