Quality and Regulatory Manager

Salary/Rate:65,000EUR - 85,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs, Quality
Job ref:25216
Post Date:04. 06. 2024

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