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Check regulatory feeds for updates since the last review and filter them by relevance to your work. Receive a digest grouped by importance, with source labels, effective dates, and comment deadlines where applicable.
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Prepare medical device regulatory strategies and submission documents for FDA, EU, and other markets. Compare application routes, organize technical and clinical evidence, draft responses to regulator questions, and track submission schedules.
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Prepare a proposed policy revision to address a specific regulatory gap. Show deletions, additions, reasons, and verification flags in a separate review memo, keeping edits limited to affected sections for the policy owner's review.
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Continue regulatory research when official sources cannot be accessed. The skill uses alternative sources or established regulatory knowledge to draft summaries and checklists, while documenting limitations and identifying the need for verification against current official requirements.
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Senior Regulatory Affairs Manager for HealthTech and MedTech. Use for regulatory strategy, FDA 510(k)/PMA/De Novo submissions, EU MDR CE marking, global market access, and regulatory intelligence.
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Review startup contracts and investment terms to identify risky clauses, prepare negotiation proposals, and organize questions for qualified attorneys. It also covers intellectual property ownership and regulatory exposure, helping founders prepare for legal review.
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Evaluates regulatory decision impact with approval probability, timeline analysis, and outcome scenario modeling for event-driven positions. Use when analyzing regulatory events, evaluating FDA/FCC/DOJ decisions, or modeling regulatory outcomes.
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Help quality leaders at medical technology companies prepare management reviews, define quality objectives, and track performance indicators. Organize audit findings, complaints, corrective actions, and regulatory status into reports and assigned improvement actions.
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Update an existing regulatory practice profile through guided, one-at-a-time changes. Adjust watched regulators, significance thresholds, policy references, feeds, or workflows while reviewing how each change affects related tasks and shared company settings.
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Track gaps between regulatory requirements and company policies, including owners, deadlines, and remediation status. Surface overdue and aging items, record resolutions or accepted risks, and prepare Slack notifications that require explicit confirmation before sending.
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Compare a regulatory change with an indexed company policy library. Identify affected policies, missing or conflicting provisions, responsible owners, and specific changes needed, with source labels and flags for uncertainty about whether the rule is in force.
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Manages responses to regulatory complaints lodged with supervisory authorities under GDPR Article 77, covering internal escalation procedures, DPA response coordination, remediation tracking, and compliance documentation. Activate for regulatory complaint, supervisory authority complaint, Art. 77, DPA response, ICO complaint queries.
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Transforms Claude into a CFA-level financial analyst for specialty finance, regulatory compliance, and industry-specific analysis. Use when performing private credit pricing, insurance reserving, FP&A variance analysis, wealth planning, restructuring recovery analysis, real estate valuation, venture capital analysis, ESG assessment, regulatory capital analysis (Basel III), compliance reporting (MiFID II, GIPS), credit derivatives (CDS, CVA), convertible bond analysis, lease accounting (ASC 842/IFRS 16), pension funding/LDI, sovereign risk assessment, real option valuation, equity research (SOTP, target price), commodity spread trading, treasury operations, PPP infrastructure modelling, onshore fund structuring, offshore fund structuring, transfer pricing analysis (BEPS, Pillar Two), tax treaty optimisation, FATCA/CRS compliance, economic substance analysis, regulatory reporting (AIFMD, Form PF), AML/KYC compliance, crypto/DeFi analysis, municipal bond analysis, structured products, trade finance, fund of funds (J-curve, commitment pacing, manager selection, secondaries), bank analytics (NIM, CAMELS, CECL, deposit beta, loan book), carbon markets (credit pricing, ETS, CBAM, offsets, shadow carbon price), or private wealth (concentrated stock, philanthropic vehicles, wealth transfer, direct indexing, family governance) analysis is required. Pairs with corp-finance-mcp tools for computation.
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Use the corp-finance-mcp server tools for specialty finance, regulatory, and compliance calculations. Invoke when performing private credit (unitranche, direct lending, syndication), insurance (loss reserving, premium pricing, Solvency II SCR), FP&A (variance analysis, break-even, working capital, rolling forecast), wealth management (retirement planning, tax-loss harvesting, estate planning), restructuring (recovery analysis, distressed debt), real assets (property valuation, project finance), venture capital (dilution, convertible instruments, fund returns), ESG (scoring, climate/carbon, green bonds, SLL), regulatory capital (Basel III, LCR/NSFR, ALM), compliance (MiFID II best execution, GIPS reporting), credit derivatives (CDS pricing, CVA/DVA), convertible bonds (binomial tree pricing, scenario analysis), lease accounting (ASC 842/IFRS 16, sale-leaseback), pension & LDI (funding analysis, liability-driven investing), sovereign risk (bond analysis, country risk), real options (binomial valuation, decision trees), equity research (SOTP, target price), commodity trading (spread analysis, storage economics), treasury management (cash management, hedge effectiveness), infrastructure finance (PPP models, concession valuation), crypto (token valuation, DeFi analysis), municipal bonds (pricing, credit analysis), structured products (notes, exotic), trade finance (LC, supply chain), fund structuring (US onshore, UK/EU, Cayman/BVI offshore, Luxembourg/Ireland), transfer pricing (BEPS/Pillar Two, intercompany pricing), tax treaty (treaty network optimization, holding structures), FATCA/CRS (reporting, entity classification), economic substance (multi-jurisdiction testing), regulatory reporting (AIFMD Annex IV, SEC Form PF, CFTC CPO-PQR), AML compliance (KYC risk scoring, sanctions screening), fund of funds (J-curve, commitment pacing, manager selection, secondaries pricing), bank analytics (NIM analysis, CAMELS rating, CECL provisioning, deposit beta, loan book), carbon markets (credit pricing, ETS compliance, CBAM, offset valuation, shadow carbon price), private wealth (concentrated stock, philanthropic vehicles, wealth transfer, direct indexing, family governance). All computation uses 128-bit decimal precision.
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Coordinates fund regulatory requirements across SEC, AIFMD, and local jurisdiction registration, reporting, and compliance obligations. Use when managing fund compliance, navigating regulatory registration, or ensuring cross-border compliance.
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Evaluates regulated utility rate-setting with RAB methodology, allowed return analysis, and regulatory reset risk assessment. Use when analyzing regulatory frameworks, modeling rate cases, or evaluating allowed return mechanics.
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Evaluates regulatory differences across jurisdictions with comparative framework analysis and optimal domicile selection. Use when analyzing regulatory environments, comparing jurisdiction frameworks, or selecting fund domiciles.
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Integrate multiple ENCODE data types (RNA-seq, ATAC-seq, Histone ChIP-seq, TF ChIP-seq) for a tissue/cell type to build a comprehensive regulatory landscape. Use when the user wants to answer "what are the enhancers, promoters, and regulatory elements active in my tissue, and which transcription factors control them?" by layering expression, chromatin accessibility, histone marks, and TF binding data. Follows the Mawla et al. 2023 framework for cross-assay integration of islet cell type-specific data. Handles chromatin state annotation (ChromHMM), enhancer-gene linkage, TF motif enrichment, and cell type-specific regulatory element identification. Use for ANY multi-omic analysis, enhancer discovery, regulatory network construction, or epigenomic characterization using ENCODE data.
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Discover and characterize regulatory elements (enhancers, promoters, silencers, insulators, super-enhancers) using ENCODE data and the cCRE catalog. Use when the user wants to find candidate regulatory elements, identify active enhancers in a tissue, map promoter states, classify chromatin states with ChromHMM, identify super-enhancers with ROSE, understand the functional validation hierarchy (CRISPR > MPRA > reporter), or characterize non-coding genomic regions. Covers the full workflow from ENCODE cCRE lookup through chromatin state segmentation to functional validation and enhancer-gene linkage. Use this skill for ANY regulatory element discovery, classification, or characterization task.
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Use when setting up or auditing how compliance documentation is structured, collected, and preserved for regulatory audit in Salesforce FSC — covering KYC data collection workflows, AML screening integration setup, audit trail configuration, and regulatory reporting readiness. Triggers: KYC form setup, AML integration configuration, compliance data collection, audit trail setup, regulatory documentation workflow, Field Audit Trail configuration, Setup Audit Trail, Event Monitoring, Discovery Framework, FSC KYC objects, Identity Document setup, Party Identity Verification. NOT for security implementation, NOT for designing AML/KYC architecture (use architect/aml-kyc-process-architecture), NOT for configuring who can access deal or client data (use admin/compliant-data-sharing-setup).
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Routes regulatory and quality management requests to one of 15 specialist skills. Helps HealthTech and MedTech teams select the right workflow for audits, medical device regulations, information security, privacy, or AI compliance.
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Review contracts, investment terms, and employment arrangements through six legal lenses. Identify key risks, organize negotiation priorities, and prepare specific questions for outside counsel before making commitments.
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Support startup AI strategy by comparing API use, fine-tuning—additional training of an existing model—and in-house development. Assess three-year costs, regulatory risk, self-hosting breakeven points, and hiring priorities to inform leadership decisions.
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Continue regulatory research when government pages or PDFs cannot be retrieved. Use alternative sources to draft compliance checklists, clearly distinguish the basis of each finding, and identify requirements that need confirmation from the relevant authority.
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