About the job
VoxelCloud is on the lookout for a dynamic and accomplished Vice President of Regulatory Affairs to lead our regulatory strategies and initiatives across all FDA-related processes throughout the lifecycle of our innovative medical imaging software solutions. This pivotal role involves direct engagement with the FDA, external legal counsel, and various stakeholders to ensure compliance and effective communication of our regulatory matters.
The successful candidate will play a crucial role in our executive team, collaborating closely with internal departments to expedite the market introduction of cutting-edge AI technologies designed for medical imaging. Additionally, this VP will be responsible for shaping, monitoring, and enhancing VoxelCloud's regulatory compliance framework.
Formulate and implement VoxelCloud's regulatory strategy, aligning with corporate objectives while assessing business risks and budget considerations.
Efficiently manage all FDA regulatory activities across the company, particularly concerning our software as a medical device (SaMD) offerings.
Act as a credible and influential spokesperson, representing VoxelCloud to regulatory bodies during pre-submission and submission processes, while articulating the advantages and developmental protocols of our AI-driven medical imaging solutions.
Oversee the preparation of regulatory submissions and compliance evaluations.
Coordinate internal and external audit processes.
Offer regulatory insights for new product development and clinical trial methodologies.
Stay informed on industry trends, regulatory changes, and legal factors, providing strategic guidance accordingly.
