Manager Global Product Registrations

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 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:

We are seeking a highly motivated and experienced Manager Product Registrations to join our growing Regulatory Affairs team. The ideal candidate will have extensive knowledge of medical device registration regulations and will be responsible for ensuring our devices are registered worldwide to enable fast time to market of the Brainlab portfolio. You will be leading the Product Registrations team at Brainlab and be acting as the counter part for Product Management and Sales in order to ensure prioritization of registrations.

Your responsibilities are to

• manage the Brainlab Product Registrations team
• lead the regulatory strategy and submissions process for new product development and product changes
• communicate effectively with regulatory authorities to obtain medical device licenses
• prepare regulatory submissions of medical devices to health authorities
• collaborate with cross-functional teams, including R&D, Product Management and Sales to ensure market availability of products
• collaborate with local partners and subsidiaries for regulatory submissions
• implement laws and regulations that impact product registrations worldwide
• maintain and improve the product registration processes and workflows
• consult in internal and external quality audits

• Degree in engineering or life sciences preferred, but other degrees may be considered
• Leadership and management skills
• Knowledge of global medical device registration regulations
• Experience in leading the regulatory submissions process for medical devices
• Ability to manage multiple projects
• Ability to work effectively in a cross-functional team
• Very strong attention to detail and ability to prioritize tasks in a fast-paced environment
• 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
• 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: Géraldine Ferrer