VoxelCloud seeks a self-motivated, highly experienced regulatory affairs professional to guide our team regarding all FDA-related matters before, during and after clinical trials. The individual will also manage and engage on our behalf with the FDA, outside counsel and other advisors regarding all VoxelCloud regulatory matters – including drafting all required company documentation.
The RA VP will be a key executive collaborating with and advising the VoxelCloud team to bring the next generation of medical imaging software and AI capabilities to the market. In addition, this VP will guide the development, monitoring and improvement of VoxelCloud's regulatory compliance processes and procedures.
Define and execute VoxelCloud’s regulatory strategy in support of company objectives - accounting for business risk, budget, and other considerations.
Plan and execute successfully and efficiently all FDA and other regulatory and compliance activities – doing so company-wide and for each of our software as a medical device (SaMD) products.
Interface externally with regulators and others as a credible, influential, respected thought leader and company spokesperson. Represent VoxelCloud to regulators during pre-submissions and submissions. Help regulators understand benefits, development processes and clinical trial protocols of our medical image AI software products.
Complete regulatory submissions and compliance assessments.
Manage internal and external audits.
Provide regulatory guidance/input for new product planning and clinical trial design.
Understand relevant industry trends, regulatory developments and legal considerations and guide us accordingly.
Demonstrated passion for improving healthcare.
5+ years successful experience driving health software through FDA clearance process (including registration, pre-sub, 510(k), De Novo, CE mark) and managing other regulatory matters for health software.
Diagnostic AI software experience is strongly preferred.
Successful startup experience preferred.
Good personal network of contacts in the health software RA field that can be leveraged to determine and implement new best practices, anticipate regulatory developments, etc.
In-depth knowledge of the U.S. healthcare system.
Successful track record of working well internally (including across groups) and externally with regulators and other stakeholders.
Outstanding communication, presentation, and leadership skills.
Excellent organizational and time management skills; detail orientation.
Strong analytical and problem-solving skills.
Willingness to roll up your sleeves to get the job done regardless of resourcing.
Open, transparent people leader who sets clear goals and standards for accountability.
Ability to manage – and thrive – amid ambiguity.
Appropriate bachelor’s degree; advanced degree preferred.
Appropriate regulatory certifications highly preferred
All information shared is confidential according to EEO guidelines.
