Staff Regulatory Affairs Engineer
Hinge HealthTelemedicine company
San Francisco, United StatesLead
Tiger Global Management
Coatue
Insight Partners
Bessemer Venture Partners
Atomico
About the role
TL;DR
Lead regulatory strategy and submissions for AI/ML Software as a Medical Device portfolio.
- •Lead regulatory strategy and submissions for Hinge Health's AI/ML Software as a Medical Device portfolio, partnering with Product, Clinical, and Engineering teams to ensure compliance and enable rapid innovation.
- •Key Responsibilities Author and lead FDA submissions (510(k), De Novo, Q-Subs) for AI/ML-enabled software.
- •Develop regulatory strategies for new products and software updates, including PCCPs.
- •Participate in design reviews and change control to assess regulatory impact of software changes.
- •Requirements Bachelor's degree in a technical/scientific field. 7+ years in Regulatory Affairs for medical devices, with 3+ years in SaMD or digital health.
- •Proven experience authoring and clearing FDA Class II submissions (510(k)/De Novo).
Required skills
Product ManagementAgileScrumCompliance ManagementRisk Management
Domain expertise
healthtech
Tech stack
PythonJavaScriptJavaC++C#GoRustRubyPHPSwiftKotlinScalaRSQLBashCObjective-CPerlLuaElixirClojureHaskellDartReactVue.jsAngularNext.jsSvelteHTMLCSS