Quality & Regulatory Affairs Lead – Medical Device Software (SaMD/SiMD)
imfusion
About this role
A Quality & Regulatory Affairs Lead position focusing on medical device software, responsible for defining quality strategies, ensuring regulatory compliance, and building a Quality Management team. The role involves active contribution to documentation, audits, and continuous improvement in a fast-growing company environment.
Skills
About imfusion
imfusion.comImFusion GmbH enables rapid innovation in medical imaging by providing consulting, R&D, and software solutions that help engineers and medtech teams build and deploy advanced imaging applications quickly. Their offerings combine practical software tools and expert algorithm development to accelerate prototyping, image processing, visualization, and integration into product or clinical workflows. ImFusion focuses on shortening the path from concept to deployment so teams can iterate and bring imaging products to market faster.
About imfusion
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Leadership Team
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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View leadership team, funding history,
and employee contacts for imfusion.
Salary
$92k – $119k
per year
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