Regulatory Affairs Expert
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.
As Regulatory Affairs expert (title will based on your knowledge and experience) 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 and/or processes.
Your duties include:
- Provide input to the development team on medical device regulatory considerations.
- Review of the technical documentation of the new/changed medical device.
- Evaluate the design changes and follow up them during development and implementation.
- Discuss general regulatory topics with colleagues from R&D and other departments (marketing, support, sales...).
- Establish global regulatory strategies for the company’s medical devices in collaboration with local partners in all Brainlab subsidiaries.
- Monitor and investigate regulatory requirements in pre-defined countries.
- Contribute and collaborate in adapting the Brainlab Quality System to new/changing regulatory requirements.
- Participate in regulatory audits and follow up improvement opportunities.
- 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 as a minimum of 3 years is requested. Previous experience in other departments related to medical device development may be considered as well (e.g. in R&D). Title and related compensation will be based on knowledge and experience.
- Strong knowledge of medical device software and related regulatory requirements (IEC 62304, IEC 82304, ISO 14971, cybersecurity...).
- Knowledge of artificial intelligence/machine learning technologies and relevant regulatory requirements is a plus.
- Excellent English written and verbal communication skills
- Ability to communicate with all stakeholders.
- Persuasive power
- 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
- 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.