Job Description

VoxelCloud seeks a self-motivated, highly experienced regulatory affairs and quality assurance professional to guide our team regarding quality assurance requirements and best practices as well as 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/QA 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 of VoxelCloud’s internal platform for quality assurance/improvement and 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.
• Establish and maintain industry-leading practices and documentation for regulatory and other excellence in healthcare AI software.
• Lead the development/refinement of VoxelCloud’s internal systems for quality assurance and regulatory compliance in alignment with the company’s evolving growth and operating phases.
• 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 before, during and after clinical trials. Help regulators understand benefits and development processes 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.
• Establish and promote quality driven product development culture in the organization.
• Implement and manage a cost-effective Quality Management System (including all documentation).
• Ensure company-wide compliance with ISO 13485 and other applicable regulations in the U.S. and later, other countries.
• Understand relevant industry trends, regulatory developments and legal considerations and guide us accordingly.

Qualifications

• Demonstrated passion for improving healthcare.
• Prior successful experience setting up QA and RA processes for an organization is required.
• 5+ years successful experience driving health software through FDA clearance process (including registration, pre-sub, 510(k), PMA, CE mark) and managing other regulatory matters for health software.
• Diagnostic AI software experience strongly preferred.
• Successful startup experience preferred.
• Strong documentation skills covering all QMS compliance and FDA matters.
• Good personal network of contacts in health software RA and QA fields that can be leveraged to determine & 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 certifications in ISO compliance and quality assurance highly preferred.

Additional Information

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