gdpr-data-handling
Safe 69Implement GDPR compliant data handling
by wshobson
GDPR requirements are complex and easy to miss during development. This skill provides clear patterns for consent management, data subject rights, and privacy by design to help you build compliant systems.
employment-contract-templates
Safe 69Generate Employment Contracts and HR Documents
by wshobson
Create legally sound employment documents quickly and consistently. This skill provides professionally drafted templates for contracts, offer letters, and HR policies that comply with employment law best practices.
risk-management-specialist
Safe 79Manage Medical Device Risk with ISO 14971 Expertise
by davila7
Medical device companies must implement comprehensive risk management throughout product lifecycle to meet regulatory requirements. This skill provides expert guidance on ISO 14971 implementation covering risk analysis, evaluation, control, and post-production monitoring.
regulatory-affairs-head
Safe 79Guide regulatory affairs for HealthTech
by davila7
HealthTech and MedTech companies need expert regulatory guidance to navigate complex FDA and EU MDR requirements. This skill provides strategic regulatory affairs leadership including submission planning, compliance frameworks, and cross-functional team coordination for successful market access.
qms-audit-expert
Safe 80Lead QMS Audits for ISO 13485 Compliance
by davila7
Quality management system audits require deep regulatory knowledge and systematic methodology. This skill provides expert guidance for ISO 13485 audits, nonconformity identification, and corrective action verification.
gdpr-dsgvo-expert
Safe 80Analyze GDPR compliance and data protection
by davila7
Organizations face complex EU GDPR and German DSGVO requirements that require specialized expertise. This skill provides expert guidance on compliance frameworks, privacy impact assessments, data subject rights management, and regulatory verification.
fda-consultant-specialist
Safe 81Navigate FDA regulations for medical devices
by davila7
Medical device companies face complex FDA compliance requirements that delay market entry. This skill provides expert guidance on FDA pathways, QSR requirements, HIPAA compliance, and regulatory submission strategies.
risk-management-specialist
Safe 80Manage medical device risk with ISO 14971 frameworks
by alirezarezvani
Medical device companies face complex risk management requirements across product lifecycles. This skill provides expert guidance for implementing ISO 14971 risk management processes including hazard identification, risk estimation, control measures, and post-market surveillance.
regulatory-affairs-head
Safe 80Lead Regulatory Strategy for Medical Devices
by alirezarezvani
Medical device companies face complex global regulatory requirements that delay market access and increase compliance costs. This skill provides expert regulatory affairs guidance for FDA submissions, EU MDR compliance, ISO certifications, and cross-functional team coordination.
quality-manager-qms-iso13485
Safe 81Implement ISO 13485 Quality Management Systems
by alirezarezvani
Medical device companies struggle to build and maintain compliant ISO 13485 quality management systems. This skill provides expert guidance on QMS implementation, documentation control, internal audits, and regulatory compliance for ISO 13485 certification.
qms-audit-expert
Safe 81Audit Quality Management Systems with ISO 13485 Expertise
by alirezarezvani
This skill provides expert guidance for planning, executing, and managing ISO 13485 audits. It includes risk-based audit planning tools, nonconformity tracking, and CAPA integration workflows for medical device organizations.
fda-consultant-specialist
Safe 81Navigate FDA medical device compliance
by alirezarezvani
Medical device companies face complex FDA regulations and HIPAA requirements. This skill provides expert guidance on 510(k) submissions, QSR compliance, and healthcare data protection for efficient market access.
capa-officer
Safe 81Manage CAPA Processes and Root Cause Analysis
by alirezarezvani
This skill provides expert-level guidance for managing Corrective and Preventive Actions within Quality Management Systems. It offers systematic root cause analysis techniques, corrective action planning frameworks, and effectiveness verification procedures for regulatory compliance.
water-rights-fishing
Safe 70Process water rights and fishing regulations efficiently
by ACSKamloops
Administrative workflows for water licenses and fishing restrictions require specialized knowledge of regional Indigenous territory regulations. This skill helps clerks efficiently navigate complex water rights and fishing regulations for Pukaist and Nlaka'pamux territories.
fiduciary-duty-negligence
Safe 70Analyze Crown fiduciary negligence documents
by ACSKamloops
Legal researchers need to systematically review and index historical records of Crown fiduciary breaches. This skill provides a clerk workflow to extract verbatim evidence from documents while maintaining legal-grade standards and neutrality.