Senior Regulatory Affairs Manager (f/m/d)

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