Company Description
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 around 2400 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.
Job Description
You are interested in Regulatory Affairs or in the development of medical devices? As QM Associate in our Regulatory Affairs team 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:

• 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

QUALIFICATIONS

• 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

• 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 requirement