Requirements
- 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
What the job involves
- 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
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