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Found 26 Skills
Senior Regulatory Affairs Manager expertise for HealthTech and MedTech companies. Provides strategic regulatory guidance, submission management, regulatory pathway analysis, global compliance coordination, and cross-functional team leadership. Use for regulatory strategy development, submission planning, regulatory risk assessment, and team coordination activities.
Conduct threat modeling using STRIDE methodology. Identify threats, assess risks, and design security controls. Use when designing secure systems or assessing application security.
Run a pre-mortem risk analysis on a PRD or launch plan. Categorizes risks as Tigers (real problems), Paper Tigers (overblown concerns), and Elephants (unspoken worries), then classifies as launch-blocking, fast-follow, or track. Use when preparing for launch, stress-testing a product plan, or identifying what could go wrong.
Plan a sprint — scope work, estimate capacity, set goals, and draft a sprint plan. Use when kicking off a new sprint, sizing a backlog against team availability (accounting for PTO and meetings), deciding what's P0 vs. stretch, or handling carryover from the last sprint.
Local-evidence production readiness audit for shipped apps, pre-launch reviews, post-merge checks, and "what breaks in prod?" questions without sending repo data to an external audit service.
Use to track pursuit risks, owners, mitigation steps, and escalation triggers.
Identify, assess, and mitigate operational risks. Trigger with "what are the risks", "risk assessment", "risk register", "what could go wrong", or when the user is evaluating risks associated with a project, vendor, process, or decision.
Use when you need to perform D1 research during the Spec-level design phase (output `{FEATURE_DIR}/design/research.md`), or when you face critical uncertainties/high-risk points that require verification first instead of directly proceeding to D2; common symptoms include lack of evidence to support trade-offs, unknown items written as TODOs/to-be-confirmed issues, attempting to guess the FEATURE_DIR under pressure, or writing research as implementation details.
Build a pre-implementation harness for ambiguous or risky coding tasks by grounding the request in the repository, producing a structured impact map, surfacing ambiguities and risks, defining scope boundaries, and creating a validation-ready implementation contract before any code changes are made. Use when a task is broad, underspecified, cross-cutting, or likely to drift without an explicit planning checkpoint.
Helps fail fast on risky implementation steps by prototyping before committing to full code changes. Use during planning or implementation when a step is ambiguous, depends on multiple subsystems or flaky tools, may invalidate the current plan, or when repeated fix attempts suggest a doom loop. Useful both at planning step and during implementation.
Use when identifying launch risks, mitigation plans, and escalation owners.
Expert legal advisor specializing in technology law, compliance, and risk mitigation. Masters contract drafting, intellectual property, data privacy, and regulatory compliance with focus on protecting business interests while enabling innovation and growth.