QM Associate - Regulatory Affairs

• 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
• Support global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries
• Support 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
• Participate in regulatory audits and follow up improvement opportunities
• Review marketing material
• Support the release of third party devices
• Train Brainlab employees in regulatory requirements

• 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 is an advantage
• Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)
• Excellent English written and verbal communication skills
• Ability to communicate with all stakeholders
• Persuasive power

Previous experience in other departments related to the development of a medical device is a plus (e.g. in R&D)

• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days, plus December 24th and December 31st
• Bike leasing via cooperation partner 'BikeLeasing'
• Parking garage and safe underground bike storage
• Award-winning subsidized company restaurant and in-house cafes
• Variety-rich fitness program in our ultra-modern 360m2 company gym
• Regular after work, team, and company events
• Comprehensive training and continuing education opportunities