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Scarlet is a regulatory technology company that helps medical device manufacturers—particularly those building AI-enabled and software-driven devices—accelerate their path to market by streamlining certification and regulatory approval processes. The company combines clinical, technical, and regulatory expertise with AI agents and software to enable rigorous certification without compromising safety.
In this role, you will own Scarlet's expansion into new regulatory approvals, certifications, and geographic markets. You'll drive this expansion end-to-end, from identifying opportunities through to securing approvals and landing the first customers.
Key responsibilities include:
**Market & Opportunity Research**: Identify and evaluate new regulatory approvals, certifications (e.g., ISO/IEC 27001, ISO/IEC 42001), and geographic markets that unlock value for Scarlet's customers. Build a strategic view of each opportunity, understand requirements, and make investment recommendations.
**Regulatory Strategy & Planning**: Translate unfamiliar regulatory systems into concrete execution plans. Partner with Scarlet's regulatory teams to determine what needs to be built, changed, or demonstrated to achieve new approvals, identify stakeholders, and map the critical path.
**Project Execution**: Own new applications end-to-end. Coordinate across internal teams, external experts, and regulatory bodies. Manage complex timelines, anticipate blockers, and drive multiple projects forward simultaneously until approvals are secured.
**Customer Acquisition**: Identify manufacturers who need the new approvals, close deals with early customers, and coordinate their journey through newly launched services.
**Process & Systems Building**: Each new approval should make the next one faster and better. Build repeatable processes, tooling, and institutional knowledge that transform one-off projects into scalable regulatory capabilities.
**Cross-functional Leadership**: These projects span commercial, regulatory, product, and people functions. You'll step into gaps, maintain momentum, and ensure seamless handovers to deployment teams once approvals are secured.
You'll work in a fast-moving startup environment where operational excellence, commercial judgment, and relentless execution are essential. The role requires someone who can synthesize information from incomplete sources, solve unfamiliar problems from first principles, and communicate clearly across technical and non-technical stakeholders.
