QM Associate Regulatory Affairs

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 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

Additional Information :

• 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

Ready to apply We look forward to receiving your online application including your first available start date and desired salary. 

Contact person: Ayline Föll

Remote Work :

No

Employment Type :

Full-time