Quality and Regulatory Manager

About The Role

Regulatory Affairs Specialist

Are you an experienced Regulatory Affairs professional interested in Artificial Intelligence?

We are currently supporting a client dedicated to advancing patient well-being through innovative AI technologies in radiology.

The company operates 100% remotely and is now looking for a Regulatory Affairs Specialist to support their team with outstanding product quality and continuous regulatory compliance, breaking the last barrier before go-to-market.

Your tasks:

• Ensuring product quality and continuous regulatory compliance.
• Support with market expansion.
• Report to Chief Medical Officer.
• Engage in product development by consulting on regulatory matters and managing risks.
• Shape process landscape and train employees to achieve operational excellence.
  
  

What is required:

• Full proficiency in Business English and German.
• Excellent written and verbal communication skills.
• Experience with regulatory affairs (MDR and ISO 13485)
• IT skills and ability to thrive in a dynamic, fully remote environment.
• Experience in MedTech / SaaS / startup environment is an advantage.
  
  

If you have any questions or you are interested in other roles within MedTech, please contact Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com