Senior Regulatory Affairs Program Manager
Hinge Health- Location
- Remote
- Work mode
- Remote
- Type
- full time
- Listed
Applications go directly to Hinge Health. Ramai takes no fee for placement and no money for ranking.
[ About this role ]
The Staff Regulatory Affairs Engineer at Hinge Health is responsible for the regulatory strategy and authorship of submissions for AI/ML Software as a Medical Device (SaMD). This role involves hands-on management of filings like 510(k) and De Novo, partnering with product and engineering teams to navigate FDA frameworks for AI/ML, and owning internal regulatory functions for the Quality Management System.
Skills and focus areas
- regulatory affairs
- ai/ml
- software as a medical device (samd)
- 510(k)
- de novo
- q-submissions
- predetermined change control plans (pccp)
- quality management system (qms)
- 21 cfr 820
- iso 13485
- design control
- change control
Summary written by Ramai from the original posting. Full details and requirements are on Hinge Health’s careers page.
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