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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 1400 dedicated and inspiring individuals in 19 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:


QM Associate – Regulatory Affairs


WHAT TO EXPECT

You are an expert in Regulatory Affairs or in the development of medical devices?

As QM Associate - Regulatory Affairs 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 and/or processes.

Your duties include:

  • Review Technical documentation before CE marking a new/changed medical device
  • Evaluate  and follow up design changes during the  development and implementation
  • Discuss regulatory topics with R&D colleagues and other departments
  • Establish global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries
  • Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, technical documentation to Health Canada, Notified Body, TGA 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 improvement opportunities
  • Train Brainlab employees in regulatory requirements

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 is an advantage
  • Excellent English written and verbal communication skills including presentation skills
  • 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