Deputy Manager

Zydus Medtech; Surat; On-site; INR 600,000 - 900,000; Full time

Job summary

Zydus Medtech seeks a Documentation Specialist to manage Design History Files, regulatory documentation, risk management records, and change controls across the product lifecycle.

You will ensure ALCOA++ compliance, maintain traceability, support audits, and collaborate with R&D, QA, Regulatory, Manufacturing, and Supply Chain teams.

The role emphasizes ISO 14971 and regulatory alignment, with timely documentation updates for regulatory reviews.

Responsibilities

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

Job description

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 Good 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