Tactile Medical Benefits Overview

Provides technical leadership for cloud-based backend services and shared platforms supporting connected medical devices and digital health applications. Defines scalable, secure, compliant architectures, service boundaries, APIs, integrations, data flows, and operational patterns. Leads architecture reviews, cybersecurity design, documentation, risk management, traceability, and regulated software release support, including FDA 510(k) activities. Collaborates with internal teams and external partners to establish architecture governance and strengthen ownership of critical technical decisions.

Leads medical device regulatory strategies and submissions across the product lifecycle, including 510(k)s, Q-submissions, global filings, UDI/GUDID maintenance, labeling reviews, audits, inspections, recalls, and regulatory documentation. Advises Engineering, Clinical, Quality, Manufacturing, Marketing, and Supply Chain teams on FDA and international requirements, manages regulatory risks and timelines, develops policies and training, and mentors regulatory professionals.

Leads medical device research and development from concept through design transfer. Owns technical scope, product specifications, prototyping, verification and validation planning, risk documentation, engineering deliverables, supplier capability evaluation, regulatory compliance, and manufacturing transfer. Collaborates with marketing, clinical, regulatory, supply chain, and manufacturing teams while developing prototypes, evaluating emerging technologies, troubleshooting design issues, and communicating project progress to stakeholders and senior leadership.