What you'll do
You will own the Regulatory area at Powerful Medical. You will ensure proper compliance and alignment with regulatory standards for our already certified products and lead the certification of new ones. For this important role, we are looking for a seasoned professional, experienced with both MDR and FDA, who wants to impact one of the most important shifts in modern medicine.
Your role
Lead the regulatory strategy of our innovative medical devices
Own general project management of our regulatory agenda
Manage, and prepare critical regulatory submissions
Develop and lead QMS processes on regulatory affairs topics
Manage our external regulatory consultants
Own communication with regulatory bodies, incl. FDA and EU Notified Body
Oversee the preparation of all necessary reports within the post-marketing surveillance activities
Monitor and analyze changes in regulations and ensure their effective implementation across departments