Role & responsibilities

Design History File (DHF) & Technical Documentation Management

- Author, compile, review, maintain, and control Design History Files (DHF), Design Dossiers, Technical Documentation, and Device Master Records (DMR).
- Ensure all design control documentation is complete, accurate, traceable, and compliant with applicable regulations.
- Maintain document integrity throughout the product development lifecycle.
- Support preparation of product documentation packages for internal and regulatory reviews.
- Manage document revisions, approvals, and archival activities

Design Controls & Traceability

- Ensure complete traceability between User Needs, Design Inputs, Design Outputs, Risk Controls, Verification, Validation, and Design Transfer activities.
- Develop and maintain Design Traceability Matrices.
- Support design review activities and maintain associated records.
- Ensure compliance with design control requirements and quality system procedures.
- Coordinate documentation activities across product development functions.

Regulatory Documentation & Product Registration Support

- Prepare and maintain technical documentation required for domestic and international regulatory submissions.
- Support EU MDR technical file preparation and maintenance activities.
- Assist Regulatory Affairs teams during product registration and submission activities.
- Ensure documentation remains aligned with evolving regulatory requirements.
- Support responses to regulatory authority documentation requests.

Risk Management Documentation

- Develop and maintain Risk Management Files in accordance with ISO 14971 requirements.
- Ensure alignment between identified risks, mitigation measures, verification evidence, and design documentation.
- Support risk assessments and risk review activities.




- Maintain risk traceability throughout product development and post-market stages.
- Participate in risk-based decision-making discussions

Change Control & Documentation Updates

- Prepare and manage Engineering Change Requests (ECR) and Engineering Change Orders (ECO).
- Support document revision control and configuration management activities.
- Ensure timely updates of lifecycle documentation following approved changes.
- Maintain document version control and change history records.
- Coordinate implementation of design and documentation changes across departments.

Quality Management System Documentation

- Author and revise SOPs, work instructions, templates, forms, and quality records.
- Ensure documentation complies with Quality Management System requirements.
- Promote Positive Documentation Practices (ALCOA++) across documentation activities.
- Support document control processes and continuous improvement initiatives.
- Maintain standardized documentation practices throughout the organization.

Audit & Compliance Support

- Support internal, external, customer, and regulatory audits.
- Prepare documentation packages for audits and inspections.
- Support CAPA investigations and documentation activities.
- Assist with audit observations, responses, and closure activities.
- Ensure ongoing audit readiness of product development documentation.

Cross-Functional Collaboration

- Collaborate with R&D;, Quality Assurance, Regulatory Affairs, Clinical Affairs, Manufacturing, Supply Chain, and Marketing teams.
- Coordinate documentation requirements with internal and external stakeholders.
- Support timely completion of project documentation deliverables.
- Facilitate effective communication regarding documentation status and compliance requirements.
- Contribute to successful product development and commercialization activities

📌 Deputy Manager (Surat)
🏢 Zydus Medtech
📍 Surat