RxFunction is a privately-held start-up medical device company headquartered in Eden Prairie with a mission to design and bring to market medical technologies that restore balance, increase mobility, and enhance confidence.
As the Director of Quality Assurance and Regulatory Affairs, this position will be responsible for ensuring global leadership in RxFunction, influencing the creation of and meeting the global regulatory requirements for the company’s emerging medical device initiatives. This position will interact with the FDA, Notified Bodies and other approval authorities as needed to develop the regulatory strategies for and manage all aspects of their execution for this novel therapy.
This position is responsible for ensuring the overall effectiveness of the quality system throughout the organization, including its ongoing compliance to regulatory requirements. It reports to the CEO and works with all critical functions of the organization.