As an expert in Regulatory Affairs (title will be 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.
Your duties include:
- Provide input to the development team on the medical device regulatory considerations.
- Review of the technical documentation of the new/changed medical device
- Evaluate and follow up design changes during the development and implementation with R&D.
- Discuss the general regulatory topics with R&D colleagues and other departments (e.g. marketing, support, sales)
- Establish global regulatory strategies for the Brainlab medical devices in collaboration with local partners in all subsidiaries
- Consult in 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
- Contribute and collaborate in adapting the Brainlab Quality System to new/changing regulatory requirements
- Participate in regulatory audits and follow up improvements opportunities