Regulatory Affairs Manager
Are you interested in the digital healthcare field?
Would you like to be part of a team who have developed a DiGA certified medical device, with the aim to help guide cancer patients through their treatment journey, by providing psychological support and expert knowledge?
We're currently supporting a Berlin-based client in their searching for a Regulatory Affairs Manager to support the successful maintenance of their QMS, ensure MDR compliance and oversee their international expansion!
- Updating and maintenance of the Quality Management System in accordance with ISO 13485
- Maintain MDR & DiGAV compliance and oversee DiGA change requests
- Implement regulatory strategies and solutions for new international markets
- Compilation and continuous maintenance of the technical file
- Overseeing products in relation to medical software, such as Data Privacy in accordance with ISO 27001
- Working cross-functionally with departments such as Product and Clinical teams to support with PMS requirements and Clinical Evaluations
- Knowledge of regulatory requirements including ISO 13485, ISO 14971, ISO 62304
- 2+ years of experience within Quality Management/Regulatory Affairs for medical devices (preferably software medical devices)
- Fluency in English, German fluency preferred
If you're interested in this position, please contact Hollie Barry for further details: firstname.lastname@example.org