Remote Instructor – GCP & Medical Device Compliance

• Deskripsi pekerjaan Remote Instructor – GCP & Medical Device Compliance AION GROUP INTERNATIONAL
• Remote Instructor – Clinical Research, ISO 13485, ISO 14971, MDR, FDA, Audits & Risk Management
• 100% Remote · Live Online Training · Modular Sessions

About Us

We deliver high-quality online training programs in clinical research (GCP) and medical device regulatory compliance (ISO/MDR/FDA).

To expand our international trainer network, we are seeking experienced remote instructors with strong backgrounds in regulatory affairs, quality management, clinical operations, or auditing.

You will train small groups (8–16 participants) in live online sessions, guiding them through interactive exercises, document analyses, and real‑world case studies.

About The Role

As a remote instructor, you will

• Deliver interactive live online classes based on our structured modular curriculum
• Explain regulatory and quality concepts clearly and with real-world applicability
• Facilitate hands‑on activities: document reviews, mock audits, risk analyses, CAPA cases
• Lead breakout room discussions & group work
• Provide feedback on assignments, CAPA exercises, or statistical tasks
• Use digital tools (Zoom/Teams, Miro, eTMF tools, mock audit templates, etc.) to enhance learning
• Required Skills (Core Competencies)

All applicants must demonstrate strong competencies in

• ICH‑GCP E6(R2) and ethical principles
• ISO 13485, ISO 14971, EU‑MDR, FDA 21 CFR 820/QMSR
• Internal, supplier, or regulatory audit experience
• ISO 19011 audit methodology
• Data integrity (ALCOA+) & secure digital data management
• Risk management documentation (FMEA, hazard analysis, risk controls)
• Professional communication & auditor‑level questioning skills
• Experience leading live online workshops
• Specialization Clusters (Select One or More)

Applicants may qualify for one or multiple clusters

1 — Regulatory & Compliance Foundations

ICH‑GCP, ISO 13485, ISO 14971

EU‑MDR / FDA QMS

• Ethics, safety, stakeholder responsibilities
• 2 — Audit Methodology & Digital Auditing

ISO 19011

• Audit planning, execution, reporting
• Remote audits
• Evidence gathering & interview techniques
• 3 — Risk Management (ISO 14971)
• FMEA (Design/Process)
• Hazard analysis
• Risk controls & benefit–risk assessment
• 4 — Clinical Operations & Data Management (GCP)
• Study setup, monitoring, RBM
• EDC systems, query handling
• AE/SAE reporting
• Data lock & inspection readiness
• 5 — Clinical Biostatistics
• Study design (RCT, adaptive, non‑inferiority)
• Power & sample size
• Statistical interpretation
• 6 — Quality Systems & Process Audits (MedTech)

QMS (ISO 13485)

• Design, production, validation audits
• PMS & complaint handling
• CAPA processes
• 7 — Design Controls & Technical Documentation

DHF, DMR, DHR

• MDR Annex II/III
• Usability (IEC 62366)
• Labeling & UDI
• 8 — Supplier Audits & MDSAP
• Supplier qualification & monitoring
• MDSAP country requirements
• Supply chain compliance
• 9 — Root Cause Analysis & Quality Improvement
• RCA (5-Why, Ishikawa, Fault Tree)
• CAPA effectiveness
• KPI & improvement programs
• Teaching Requirements (Remote Delivery)
• Must be comfortable delivering interactive online training including:
• Mock interviews
• Document reviews
• Risk analyses
• Audit walkthroughs
• CAPA workshops
• Interactive tasks (whiteboarding, shared docs, group activities)
• Teaching Format
• 100% remote (live online)
• Training materials/templates provided or co‑created
• Compensation
• Please provide your daily remote training rate
• Prep work can be compensated upon agreement
• Long‑term collaboration and repeated module delivery possible
• How to Apply

Please submit

• CV or LinkedIn profile
• Selected specialization clusters (1–9)
• Short description of your remote teaching experience
• Your daily rate
• Sample materials (audit reports, risk analyses, tech docs, slides, etc.)
• Availability (modules run 1–4 days each)