Designation – Technical Documentation Specialist (Senior Executive)Experience:3-8 years in Medical Device Industry with direct experience in Design Controls, Technical Documentation, DHF Management, Regulatory Documentation, or Quality Systems. Experience in cardiovascular medical devices and international regulatory submissions will be preferred.Required Skills & ExperienceTechnical Writing & Documentation ManagementDesign History File (DHF) PreparationDevice Master Record (DMR) ManagementTechnical Documentation & Design DossiersRisk Management Documentation (ISO 14971)Regulatory Documentation & Product Registration SupportDesign Control RequirementsChange Control (ECR/ECO)CAPA Systems KnowledgeTraceability Matrix DevelopmentQuality Management System DocumentationStrong Communication & Cross-functional CollaborationMS Office & Document Control Systems ProficiencyKey CompetenciesTechnical:Technical Writing and DocumentationDesign Controls DocumentationRisk-Based ThinkingRegulatory DocumentationTraceability ManagementRoot Cause AnalysisQuality Systems ComplianceBehavioural:Solid Attention to DetailExcellent Communication SkillsAnalytical ThinkingProblem SolvingTeam CollaborationPlanning and OrganizationAccountabilityContinuous Improvement MindsetQualifications and Experience:Bachelor’s degree in engineering, Life Sciences, Pharmacy, or related discipline.Master’s degree in quality assurance, Regulatory Affairs, or related field preferred.3 to 5 years of experience in regulated medical device environments.Experience supporting product development from concept through commercialization.Experience with ISO 13485, ISO 14971, EU MDR 2017/745, Design Controls, Technical Documentation, CAPA Systems, and Change Control processes.Experience supporting international regulatory submissions preferred.

📌 Technical Documentation Specialist (Surat)
🏢 Zydus Medtech
📍 Surat