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. As a Corporate Start-Up based in Freiburg, Germany, B. Braun New Ventures takes a lead role in the digital transformation of healthcare. With a young and fast-growing team, we develop solutions to automate medical procedures across various business areas. Our goal is to augment caregivers’ eyes, hands and decision making with sensors, robotics, and artificial intelligence. Our cloud platform team is focused on creating corporate-wide solutions that will drive the next generation of B. Braun’s digital products and connected devices. The technologies and products we develop create new treatment possibilities, enable sharing of clinical experience, and result in better patient care.

Duties and Responsibilities:

• You play a pivotal role in evaluating and ensuring that the medical devices developed are safe, effective and comply with applicable regulations
• You lead the creation of clinical evaluations, review existing clinical data and coordinate with clinical research organizations
• You partner closely with Medical and Regulatory Affairs Teams of our partner units at B. Braun
• You support the preparation and compilation of regulatory dossiers for medical devices in the European and US market (MDR and FDA)
• You collaborate with product owners and R&D, quality managers, usability and test engineers to integrate regulatory requirements and clinical insights into the product lifecycle
• You review and support the definition of product claims and promotional materials
• You monitor changes in global medical device regulations, standards and guidelines, and update quality processes accordingly

Professional competencies:

• You have a degree in natural sciences, technology, engineering, medicine or a comparable degree, or have acquired a comparable qualification
• You have relevant professional experiences in the field of regulatory affairs, quality management or technical documentation within the medical device industry
• You have profound knowledge of medical device regulations, directives and standards
• You have successfully prepared regulatory submissions and responded to inquiries from notified bodies and authorities
• You have been in a lead role to review and maintain technical documentation
• You have an attention to details and master analytical thinking to assess clinical and regulatory risks
• You are fluent in German and English

Personal competencies:

• Exceptional interfacing skills to effectively communicate with internal functions, external agencies, health care professionals, and notified bodies
• 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 can balance well between quality and time requirements and deliver results even under time pressure
• You interact constructively, take responsibility and share your knowledge proactively

Benefits:

• Flexible and family-oriented working hours and hybrid working between office and home
• A brand-new modern office optimized for concentration and collaboration with an integrated high-tech simulation operating room and generous social areas and creativity zones
• High quality of life in one of Germany’s most attractive cities
• Subsidy for public transportation

B. Braun New Ventures GmbH | Haakon Schröder | +4916095704687