Regulatory Affairs Manager

  • Location

    Berlin, Germany

  • Sector:

    Regulatory Affairs, Quality

  • Salary:

    60,000EUR - 70,000EUR

  • Contact:

    Hollie Barry PSRC

  • Job ref:

    21525

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!
 

Focuses:

  • 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

 

Experience required:

  • 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: hollie.barry@adaptivelifescience.com