Director of Regulatory Affairs & Quality Assurance (RA/QA)
We're working closely with the C-suite at an exciting medical-device company to recruit a Director of Regulatory Affairs & Quality Assurance, who will lead the development and execution of comprehensive regulatory and quality systems. This role is pivotal in both securing immediate FDA 510(k) approval for next-generation products and laying the groundwork for scalable operations that will support future growth.
What You'll Do:
- Own the regulatory function, including managing a small regulatory team.
- Lead efforts to obtain FDA 510(k) clearance, working closely with internal teams and external partners.
- Design and execute clinical validation studies.
- Build and implement quality assurance systems from the ground up.
- Ensure compliance with US and global regulatory standards, including European regulations.
- Collaborate with internal stakeholders and external clinicians at major US medical facilities.
- Work in a flexible, hands-on environment where you will create and implement new processes.