Senior Regulatory Affairs Specialist
Regulatory operations for SaMD products across development, submission, launch, and post‑market phases with cross‑functional coordination.
Remote • United States
- Full Time
- Min. 5 YOE
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Regulatory operations for SaMD products across development, submission, launch, and post‑market phases with cross‑functional coordination.
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Leads mobile app UX/UI design, builds design systems, and drives cross-functional collaboration to improve user outcomes.
Owns materials planning and execution to optimize supply availability, mitigate risks, and coordinate with CM/ suppliers for NPI readiness.
Own and evolve mobile CI systems at scale - design, maintain, and improve pipelines for iOS and Android.
Develop high-fidelity 3D CAD models and visualizations for production-ready hardware, optimizing for prototyping and manufacturing.
Provide strategic support to Hardware and Product leaders; bridge Global Administration and Hardware Product orgs across time zones.
Develop power management firmware for battery charging systems and PMIC integration across wearable devices and product categories.
Define and ship health intelligence experiences by leading product vision, AI features, and cross‑functional roadmaps.
Lead analytics strategy and governance across data lifecycle to enable global decision-making and business growth.
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Drive miniaturization and ultra-low power operation through custom hardware development, power modeling, and hardware/software optimization.
Own partner relationships post-signature and drive performance, onboarding, and internal collaboration to scale ecosystem partnerships.
Own end-to-end production plans, balancing demand, capacity, and inventory targets with data-driven visibility.
Own end‑to‑end supplier and commodity strategy for battery cells and packs, including supplier selection, commercial structures, capacity alignment, and long‑term roadmap positioning.
Coordinate hardware engineering programs across electrical, mechanical, firmware, system test and hardware compliance to ensure on-time launches.