Job Description Template - ISO 13485

Ensure clear role definitions and competency management with our ISO 13485:2016 Clause 6.2 Job Description Template. Properly documented job descriptions are essential for ensuring personnel competency, regulatory compliance, and quality management in medical device manufacturing. This structured template helps organizations define roles, responsibilities, and required qualifications in alignment with ISO 13485:2016, MDR, IVDR, and FDA 21 CFR Part 820 requirements.

✔ Pre-Formatted Job Description Template – Covers key ISO 13485:2016 Clause 6.2 requirements.

✔ Role & Responsibilities Section – Clearly define duties and expectations for each job position.

✔ Required Qualifications & Competency Criteria – Ensure employees meet regulatory and operational needs.

✔ Training & Development Needs – Identify necessary skills, certifications, and ongoing training.

✔ Reporting Structure & Accountability – Define who the employee reports to and interacts with.

✔ Regulatory & Quality System Responsibilities – Align with QMS, risk management, and compliance obligations.

✔ Editable Digital Format – Fully customizable for various roles within medical device organizations.

This ready-to-use job description template is ideal for HR teams, quality managers, and regulatory professionals, ensuring structured, compliant, and well-defined role management.

Download the ISO 13485:2016 Job Description Template today and strengthen your competency framework and regulatory compliance!