You are an expert in Regulatory Affairs or in the development of medical devices?
As QM Associate - Regulatory Affairs 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:
- 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
- Establish global regulatory strategies for Brainlab medical devices in collaboration with local partners in our subsidiaries
- Compile regulatory submissions to be send to authorities e.g. 510(k) submissions to FDA, technical documentation to Health Canada, Notified Body, TGA 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 improvement opportunities
- Train Brainlab employees in regulatory requirements