Head of Global Regulatory Affairs

Salary/Rate:70,000EUR - 80,000EUR
Job type:Perm
Business Sectors:Regulatory Affairs, Quality
Job ref:25182
Post Date:23. 05. 2024

About the Role

Head of Global Regulatory Affairs  

Are you an experienced Regulatory Affairs professional who is passionate about utilizing AI to make a global impact in healthcare?

Our Berlin-based client, an innovator in AI-driven diagnostic solutions, is currently looking for a Global Head of Regulatory Affairs. This role offers home office flexibility and the chance to lead a global team as they expand into international markets, including the US. You would oversee compliance, lead two employees, coordinate teams in India and Egypt, and support market access initiatives.

Your tasks: 

  • Design and monitor processes according to ISO 13485
  • Lead the regulatory development of certified, AI-based medical devices
  • Expand their software to new international markets, including the USA
  • Oversee risk management in accordance with ISO 14971
  • Support the product team throughout the product lifecycle, and liaise with government agencies to uphold safety and effectiveness.
  • Collaborate on data protection and IT security issues.

Your Profile

  • Experience with ISO 13485 for medical devices, preferably in SaMD.
  • Knowledge of MDR, IEC 62304, ISO 14971, etc.
  • +5 years of experience in Regulatory Affairs within medical technology
  • Strong sense of responsibility and organization
  • Excellent communication skills in English and German

What is offered:

  • A dynamic, results-oriented work environment with flexible office/home options.
  • Opportunities for skill development through conferences, workshops, and seminars.
  • Regular team events to enhance corporate culture and solidarity.

If you're ready to pioneer the future of AI in healthcare, apply now!

If you have any questions regarding the position, please contact: Dominika Wyrwinska at dominika.wyrwinska@adaptivelifescience.com