Jobbeschreibung
You're an important part of our future. Hopefully, we're also a part of yours! At B. Braun, we protect and improve the health of people worldwide. This is also our vision for research and development. You see complexity as an opportunity – and quality and sustainability are important criteria for your work. We would like to work with you on tomorrow's solutions. That's how we work to create sustainable healthcare – locally, in regions, countries and worldwide. Together. That's Sharing Expertise.
Senior Regulatory Affairs Manager (f/m/d)
Full or Part time more than 80 % possible
Reference Code DE-1902024-89184
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
- 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
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