Vice President, Regulatory Affairs

VoxelCloud; Los Angeles (CA); On-site; USD 250,000 - 320,000; Full time

Job summary

VoxelCloud seeks a senior regulatory affairs executive to guide FDA-related matters for SaMD products, from pre-submission through clearance and post-market activities.

The RA VP will lead regulatory strategy, engage regulators and advisors, and ensure compliant processes across the organization, shaping next-generation medical imaging software and AI capabilities.

Qualifications

• 5+ years successful experience driving health software through FDA clearance (including registration, pre-sub, 510(k), De Novo, CE mark).
• Strong leadership and cross-functional collaboration across teams.
• Excellent communication and problem-solving for regulatory strategy.

Responsibilities

• Define and execute regulatory strategy for SaMD products.
• Plan and manage FDA submissions and regulatory filings.
• Interface with regulators, outside counsel, and advisors.
• Develop and monitor regulatory compliance processes and procedures.
• Provide input for product planning and clinical trial design.

Skills

Regulatory leadership

FDA submissions

Cross-functional collaboration

Strategic planning

Education

Bachelor's degree

Advanced degree preferred

Job description

Founded in 2016, VoxelCloud, Inc. is a Los Angeles-based worldwide leader in AI analysis of medical images and video. VoxelCloud’s offerings help healthcare providers make better/earlier diagnoses and related clinical decisions, improving outcomes for all. Current solutions cover cancer, cardiovascular and retinal diseases.

VoxelCloud is backed by Sequoia Capital and Tencent with a total funding of $78.5M (Series B).

We attract accomplished executives who want to work with super-smart, passionate people on cutting edge AI software that can literally save lives.

Job Description

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.

Qualifications

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

Additional Information

All information shared is confidential according to EEO guidelines.