Explore skills

EU MDR 2017/745 regulation specialist and consultant for medical device requirement management. Provides comprehensive MDR compliance expertise, gap analysis, technical documentation guidance, clinical evidence requirements, and post-market surveillance implementation. Use for MDR compliance assessment, classification decisions, technical file preparation, and regulatory requirement interpretation

Comprehensive Microsoft 365 tenant administration skill for setup, configuration, user management, security policies, and organizational structure optimization for Global Administrators

Comprehensive toolkit for product managers including RICE prioritization, customer interview analysis, PRD templates, discovery frameworks, and go-to-market strategies. Use for feature prioritization, user research synthesis, requirement documentation, and product strategy development.

Strategic product leadership toolkit for Head of Product including OKR cascade generation, market analysis, vision setting, and team scaling. Use for strategic planning, goal alignment, competitive analysis, and organizational design.

Senior QMS Audit Expert for internal and external quality management system auditing. Provides ISO 13485 audit expertise, audit program management, nonconformity identification, and corrective action verification. Use for internal audit planning, external audit preparation, audit execution, and audit follow-up activities.

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.

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 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.

Senior Risk Management specialist for medical device companies implementing ISO 14971 risk management throughout product lifecycle. Provides risk analysis, risk evaluation, risk control, and post-production information analysis. Use for risk management planning, risk assessments, risk control verification, and risk management file maintenance.

World-class computer vision skill for image/video processing, object detection, segmentation, and visual AI systems. Expertise in PyTorch, OpenCV, YOLO, SAM, diffusion models, and vision transformers. Includes 3D vision, video analysis, real-time processing, and production deployment. Use when building vision AI systems, implementing object detection, training custom vision models, or optimizing i

Comprehensive SecOps skill for application security, vulnerability management, compliance, and secure development practices. Includes security scanning, vulnerability assessment, compliance checking, and security automation. Use when implementing security controls, conducting security audits, responding to vulnerabilities, or ensuring compliance requirements.

Comprehensive security engineering skill for application security, penetration testing, security architecture, and compliance auditing. Includes security assessment tools, threat modeling, crypto implementation, and security automation. Use when designing security architecture, conducting penetration tests, implementing cryptography, or performing security audits.