职业

合规官

1929 个技能

AI 推荐

1929 个技能

Vendor Risk Brief

对外部 SaaS/API 形成风险摘要，聚焦集成影响、权限、数据流向和替代方案。；use for vendor-risk, saas, security workflows；do not use for 冒充安全认证结论, 替代正式法务/安全审批.

openclaw4.2k

项目管理

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.

openclaw4.2k

实验室工具

Qms Audit Expert

ISO 13485 internal audit expertise for medical device QMS. Covers audit planning, execution, nonconformity classification, and CAPA verification. Use for internal audit planning, audit execution, finding classification, external audit preparation, or audit program management.

openclaw4.2k

项目管理

Compliance Readiness

AI Compliance Readiness Assessment — evaluate how prepared an organization is for AI governance regulations (EU AI Act, NIST AI RMF, HHS mandates, state bar AI rules). Scores readiness across 8 dimensions and generates an action plan. Use when assessing AI compliance gaps, preparing for audits, or building a governance roadmap.

openclaw4.2k

销售与营销

Head of Regulatory Affairs

Senior Regulatory Affairs Manager for HealthTech and MedTech companies. Prepares FDA 510(k), De Novo, and PMA submission packages; analyzes regulatory pathways for new medical devices; drafts responses to FDA deficiency letters and Notified Body queries; develops CE marking technical documentation under EU MDR 2017/745; coordinates multi-market approval strategies across FDA, EU, Health Canada, PMDA, and NMPA; and maintains regulatory intelligence on evolving standards. Use when users need to plan or execute FDA submissions, navigate 510(k) or PMA approval processes, achieve CE marking, prepare pre-submission meeting materials, write regulatory strategy documents, respond to agency queries, or manage compliance documentation for medical device market access.

openclaw4.2k

计算化学

Fda Consultant Specialist

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.

openclaw4.2k

合规官

Vendor Risk Brief

Capa Officer

Qms Audit Expert

Compliance Readiness

Head of Regulatory Affairs

Fda Consultant Specialist

合规官

Vendor Risk Brief

Capa Officer

Qms Audit Expert

Compliance Readiness

Head of Regulatory Affairs

Fda Consultant Specialist

Quality Documentation Manager

Quality Manager - QMS ISO 13485 Specialist

Openfec

Compliance Officer

Compliance Readiness

Mdr 745 Specialist

Homestruk Tenant Screening

Mortgage Compliance

Regulatory Analysis

Document Review

ISO 13485 Certification Documentation Assistant

Imperial Petition Submission

Judicial Investigation Procedure

Military Justice Deliberation Process

wu-yc-labclaw-skills-med-iso-13485-certification-skill-md

Arckit Dpia

Arckit Atrs

Distill Protocol

Scoring Optimizer — Evaluation Score Optimization Tool

Permit Requirements DB — Industry-Specific Permit & License Requirements Database

Regulatory Filing

Internal Control Framework

Audit Checklist Engine

Sustainability Audit