QM Associate – Product Registrations (part-time 20h/week)

At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.

Our key to success is our creative, talented and hard-working team, which consists of around 2000 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.

At Brainlab, we develop innovative medical devices to make an impact for healthcare providers, physicians and their patients. As a QM Associate – Product Registrations you will be part of the international Regulatory Affairs team overseeing and managing medical device approvals around the world. Your goal is the worldwide registration of the Brainlab medical devices in correspondence with regulatory authorities (e.g. Health Canada, Australian TGA) in order to make our technology available to hospitals and patients around the world.

Your responsibilities are to

• prepare regulatory submissions of medical devices to health authorities
• support local partners in the preparation of regulatory submissions
• monitor and implement laws and regulations that impact product registrations
• keep regulatory databases up-to-date
• support the maintenance and improvement of the product registration processes
• participate in and support internal and external quality audits
• Degree in engineering or life sciences preferred, but other degrees may be considered
• Interest in quality management and regulatory affairs
• Knowledge of international regulations for medical devices is an advantage
• Ability to manage multiple projects
• Very strong attention to detail
• Proficient in the use of MS Office
• Excellent communication skills in English; Other languages are an advantage
• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days, plus December 24th and December 31st
• Flexible working hours as well as hybrid work model within Germany
• 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