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Jobs at Brainlab

Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of 1500 dedicated and inspiring individuals in 20 offices worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values of inspiration, simplicity and integrity:

Regulatory Affairs Specialist

  • Munich, Germany
  • Full-time
  • Department: Quality Management

WHAT TO EXPECT

As an expert in Regulatory Affairs (title will be based on your knowledge and experience) you will interact with Brainlab departments and partners internationally and Regulatory Agencies from all over the world. In a cross-functional team you will be involved in the development of various Brainlab products and be responsible for establishing the regulatory strategy. You will interpret regulatory requirements and implement them in projects.

Your duties include:

  • Provide input to the development team on the medical device regulatory considerations.
  • Review of the technical documentation of the new/changed medical device
  • Evaluate and follow up design changes during the development and implementation with R&D.
  • Discuss the general regulatory topics with R&D colleagues and other departments (e.g. marketing, support, sales)
  • Establish global regulatory strategies for the Brainlab medical devices in collaboration with local partners in all subsidiaries
  • Consult in regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, the Notified Body and other authorities
  • Monitor & investigate regulatory requirements in pre-defined countries
  • Contribute and collaborate in adapting the Brainlab Quality System to new/changing regulatory requirements
  • Participate in regulatory audits and follow up improvements opportunities

WHAT YOU OFFER

  • Degree in engineering or life sciences preferred, but other degrees may be considered
  • Professional experience in regulatory affairs or regulatory compliance in the medical device field as a minimum of 2 years is requested. Previous experience in other departments related to the development of a medical device may be considered as well (e.g. in R&D). Title and related compensation will be based on knowledge and experience.
  • Good knowledge of medical device software and related regulatory requirements (Cybersecurity, IEC 62304, IEC 82304, ISO 14971, etc.)
  • Knowledge of artificial intelligence technologies is considered a plus
  • Excellent English written and verbal communication skills
  • Ability to communicate with all stakeholders
  • Persuasive power

WHAT WE OFFER

  • working in a team of great colleagues who help and support each other
  • seeing your work making a positive impact on the daily work of clinicians around the world
  • 30 days of vacation, plus 24.12. and 31.12. 
  • flexible working hours
  • free gym courses with showers and changing rooms
  • secure bicycle storage room
  • unlimited coffee, tea and water
  • excellent subsidized restaurant
  • regular after-work, team & company events
  • comprehensive education and training opportunities, digital language courses

A position at Brainlab means that you’ll be part of a professional business environment working together with an excellent international team. You will be a valued member of a team of likeminded individuals. You’ll be assessed fairly and given great opportunities based on your performance.

Ready to apply? We look forward to receiving your online application including a motivation letter, your first available start date and desired salary.  

Contact person: Géraldine Endres