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Found 20 Skills
Validate systems and processes against GDPR/CCPA privacy regulations, privacy-by-design principles, ADA/WCAG accessibility standards, data processing agreements (DPAs), and provide compliance checklists with regulatory change monitoring guidance.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides overall quality system responsibility, regulatory compliance oversight, management accountability, and strategic quality leadership. Use for quality system governance, regulatory compliance oversight, management responsibility, and quality strategic planning.
Senior CAPA Officer specialist for managing Corrective and Preventive Actions within Quality Management Systems. Provides CAPA process management, root cause analysis, effectiveness verification, and continuous improvement coordination. Use for CAPA investigations, corrective action planning, preventive action implementation, and CAPA system optimization.
Conduct enterprise-grade financial research with multi-source synthesis, regulatory compliance tracking, and verified market analysis. Use when user needs comprehensive financial analysis requiring 10+ sources, verified claims, market comparisons, or investment research. Triggers include "financial research", "market analysis", "investment analysis", "due diligence", "financial deep dive", "compare stocks/funds", or "analyze [company/sector]". Do NOT use for simple stock quotes, basic company lookups, or questions answerable with 1-2 searches.
ISO 13485 Quality Management System specialist for medical device companies. Provides QMS implementation, maintenance, process optimization, and compliance expertise. Use for QMS design, documentation control, management review, internal auditing, corrective actions, and ISO 13485 certification activities.
Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech companies. Provides quality system governance, management review leadership, regulatory compliance oversight, and quality performance monitoring per ISO 13485 Clause 5.5.2.
CAPA system management for medical device QMS. Covers root cause analysis, corrective action planning, effectiveness verification, and CAPA metrics. Use for CAPA investigations, 5-Why analysis, fishbone diagrams, root cause determination, corrective action tracking, effectiveness verification, or CAPA program optimization.
FDA regulatory consultant for medical device companies. Provides 510(k)/PMA/De Novo pathway guidance, QSR (21 CFR 820) compliance, HIPAA assessments, and device cybersecurity. Use when user mentions FDA submission, 510(k), PMA, De Novo, QSR, premarket, predicate device, substantial equivalence, HIPAA medical device, or FDA cybersecurity.
Draft privacy policies, terms of service, disclaimers, and legal notices. Creates GDPR-compliant texts, cookie policies, and data processing agreements. Use PROACTIVELY for legal documentation, compliance texts, or regulatory requirements.
Responsible AI development and ethical considerations. Use when evaluating AI bias, implementing fairness measures, conducting ethical assessments, or ensuring AI systems align with human values.
Medical device risk management specialist implementing ISO 14971 throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis.
Legal and compliance expertise for corporate governance, contract analysis, regulatory compliance (SOX, GDPR, HIPAA), risk assessment, intellectual property, and litigation management. Use when reviewing contracts, ensuring compliance, or managing legal risk.