Vice President of Regulatory Affairs, VoxelCloud
Automated medical image analysis
Open for applications
Automated medical image analysis
1-20 employees
Open for applications
1-20 employees
Company mission
To enhance the quality of healthcare with AI – improving outcomes for all.
Role
Who you are
- 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
Our take
VoxelCloud offers healthcare providers automated medical image analytics powered by AI, assisting in the diagnosis of conditions such as lung cancer, retinal diseases, and coronary heart disease, with plans to expand this list in the future.
Since its launch in 2016, VoxelCloud has primarily focused on the Chinese healthcare market, as indicated by its offices in China and major investors like Shenzhen Hongtai Capital Management Group, Quingsong Fund, and Hanfor Capital Management.
Now, with a leadership change and preparations for US clinical trials, VocxelCloud is poised for expansion into the American market. By leveraging its successes in China, the company aims to enhance its product offerings and broaden its reach in AI-assisted medical diagnostics.
Kirsty
Company Specialist at Welcome to the Jungle
Insights
Company
Funding (last 2 of 4 rounds)
Dec 2018
$50m
SERIES B
Oct 2017
$15m
SERIES A
Total funding: $78.5m
Company HQ
Westwood, Los Angeles, CA
Leadership
Demetri Terzopoulos
(Co-Founder & Chief Scientist)Chancellor's Professor of Computer Science at University of California, Los Angeles, holding the rank of Distinguished Professor. Directs the UCLA Computer Graphics & Vision Laboratory.
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