One of our clients based in the South of the country (near Karlsruhe) – world’s leading manufacturer of dental products sold globally are currently looking for a curious Validation Expert, that is not afraid to branch out into other departments to actively contribute to company’s success.
Some of your tasks would include:
- Independent planning, implementation and monitoring of qualifications/validations for medical technology, production plants and processes, ensuring compliance with the current Regulatory requirements in as well as outside of EU.
- Creation & maintenance of the relevant paperwork for the technical documentation in accordance with EU MDR 2017/745.
- Planning and documentation of studies to prove the stability in use and transport.
- Supporting of general Quality Management activities, such as nonconformities and/or change management.
- Completed technical or scientific studies, preferably in medical device sector as well as previous experience in a similar role.
- Previous experience in the field of Quality Management & Regulatory Affairs, as well as working knowledge of current regulations (EU MDR 201/745, FDA etc)
- Excellent communication skills to include fluency in both English & German.
- Ability to work in an analytical and structured way.
Please apply with your CV or contact Kasia Krasuska for further details on this opportunity and additional vacancies in Regulatory Affairs and Quality Management.
+49 30 16 63 83 76