Senior Regulatory Affairs Manager (f/m/d)

at  neuroloop GmbH

For neuroloop® we are currently looking for a Senior Regulatory Affairs Manager (f/m/d).
neuroloop® is a subsidiary of Aesculap AG, which was founded as a spin-off of the University of Freiburg and the Freiburg University Hospital. Based in Freiburg, we are developing a plat-form for the stimulation of the vagus nerve for the treatment of chronic diseases in connection with autonomous body functions. The core of our platform is a multichannel cuff electrode based on thin-film technology that allows us to selectively stimulate specific fibers in the nerve. Our first product, the baroloop® stimulator, is specifically designed for the treatment of high blood pressure. Our main focus is to provide excellent clinical effectiveness while minimizing risks and side effects for the patient and a simple and safe use for the caregiver.

• You will prepare and compile regulatory submission dossiers for new medical device registrations and changes to existing products, in accordance with regulations
• The area of your responsibility comprises successful approval of medical devices (Class III) in the European and US market (MDR and FDA)
• You will monitor new legislations, policies, standards and guidelines that affect the assigned product portfolio.
• You will conduct post-market surveillance and report adverse events/field safety corrective actions to the authorities
• In your role you will be supporting currently marketed products, e.g, review engineering changes, product labeling and promotional materials