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.
Duties and responsibilities
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
Professional competencies
You have a degree in natural sciences, technology, engineering, medicine or a comparable degree or have acquired a comparable qualification
You have several years of relevant professional experience in the field of medical device regulation
You have extensive knowledge of regulatory affairs with a focus on international product approvals
You have in-depth knowledge of European and international medical device regulations, directives and standards
For communication in our international team your good skills in written and spoken German and English are required
Personal competencies
Collaboration with cross-functional teams to collect necessary information is a daily mission for you
You are enthusiastic about mastering challenges in a team and show the necessary stamina when things get difficult.
You have a positive attitude and communicate in an open and direct manner
You impress with your performance and achieve outstanding results
You interact constructively, take responsibility and share your knowledge actively
What we offer
Become part of a corporate culture that fosters accountability, diversity and trust within a dynamic family-owned company. Work in a start-up environment with short lines of communication and quick decision-making, but with the opportunities and security of a global healthcare leader. Take over an exciting role in a company that is working to develop the next generation of active medical implants. You can expect a variety of tasks and challenges that will allow you to grow.
Benefits
A family-friendly atmosphere with flexible working hours
Performance-related remuneration.
A brand new, modern office optimized for concentration and collaboration and generous social areas and creativity zones
High quality life in one of Germany´s most attractive cities
