Senior Executive - Design Documentation and Validation

Overview

We are seeking a Senior Executive specialized in Design Documentation and Validation to join our Endoscopy and Women Healthcare department based in Vapi, Gujarat. The individual will play a pivotal role in preparing, maintaining, and overseeing design documentation throughout the medical device product lifecycle, ensuring strict adherence to international regulatory standards and quality management systems such as ISO 13485 and MDR.

Primary Duties

• Manage and maintain comprehensive design records including Design History Files (DHF), Device Master Records (DMR), and technical documentation throughout product development.
• Develop and update Design and Development plans, user requirements, inputs and outputs, review logs, and change records.
• Handle engineering change documents ensuring version control and document integrity per quality protocols.
• Coordinate design verification and validation (V&V) activities including planning, conducting, and reporting in collaboration with R&D and quality teams.
• Perform detailed risk management tasks aligned with ISO 14971, including creating risk plans, analyses (DFMEA/PFMEA), and maintaining risk documentation through the product lifecycle.
• Support creation and maintenance of regulatory dossiers for submissions to bodies such as CDSCO, FDA, and CE marking authorities.
• Collaborate cross-functionally with teams spanning R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Project Management to facilitate design transfers and documentation readiness.
• Maintain document templates, ensure timely approvals, and support electronic document management systems to uphold audit preparedness.

Qualifications

• Bachelor's or Master's degree in Biomedical, Electronics, Mechanical Engineering, Medical Instrumentation, or related fields.
• 6 to 8 years of relevant experience in medical device design assurance, regulatory documentation, or product development within regulated environments.
• Familiarity with global medical device regulations is highly advantageous.

Skills and Expertise

• Deep knowledge of Design Controls and DHF management.
• Proficiency with ISO 13485, ISO 14971, EU MDR, FDA 21 CFR Part 820, and CDSCO standards.
• Experience preparing and managing V&V documentation.
• Risk management expertise including DFMEA, PFMEA, and hazard analysis methodologies.
• Strong technical writing, analytical thought, organizational skill, and project management capabilities.
• Proficient in Microsoft Office and document management systems like PLM, QMS, and EDMS.
• Effective communicator comfortable working in cross-disciplinary teams.

Performance Metrics

• Adherence to timelines for design documentation completion and updates.
• High accuracy and completeness of technical and regulatory files.
• Successful support for regulatory submissions and audit processes.
• Maintaining compliance with all relevant quality and regulatory standards.
• Efficient cross-functional collaboration to support project milestones.
• Prompt resolution of documentation issues identified during reviews and audits.