Job Description
 Global Market Registration Prepare and maintain Technical Documentation (TD) in accordance with EU MDR 2017/745Annex II & III Support Design History File (DHF) development, ensuring completeness across designinput/output, verification, validation, and traceability. Lead risk management activities as per ISO 14971, including risk files and FMEA. Experience in software lifecycle documentation in line with IEC 62304 and usability files perIEC 62366. Coordinate verification and validation summaries, including: Electrical Safety (IEC 60601-1) Biocompatibility (ISO 10993-1) Software Validation Mechanical Testing and EMC Create and update documents for change management, remediation, and gap analysisprojects.
 Assist in developing US FDA 510(k), EUMDR or other country-specific dossiers.

Roles & Responsibilities
 Review Design History File (DHF) and associated technical documentation
 Assess completeness and compliance against EU MDR Annex II & III requirements
 Identify documentation gaps, inconsistencies, and missing evidence.
 Perform clause-by-clause assessment against applicable standards such as:
 ISO 14971 (Risk Management)
 IEC 62304 (Software Lifecycle)
 IEC 62366-1 (Usability Engineering)
 IEC 60601 series (where applicable)
 Determine applicability, available evidence, justification needs, and remediation actions
 Review risk analysis, hazard analysis, FMEA, and risk management reports
 Assess traceability between hazards, risk controls,



verification evidence, and residual risk

evaluation
 Support preparation or update of risk documentation where required
 Update standards mapping templates with:
 Evidence references
 Justifications for non-applicability
 Recommended remediation actions
 Maintain structured documentation review logs.

Specific Technical Skills & Regulatory Expertise

 Proficient in ISO 13485, EU MDR, and standards like ISO 14971 (Risk Management) IEC 60601-1 (Electrical Safety) IEC 62304 (Medical Software Lifecycle) ISO 10993-1 (Biocompatibility) Hands-on experience in preparing technical files, risk files, traceability matrices, and V&Vdocumentation.; Working knowledge of document change control, gap assessments, Working knowledge of EU MDR requirements Understanding of ISO 14971 risk management process
Familiarity with IEC 62304 and software documentation

General Skills
 Robust analytical and problem-solving skills with a risk-based approach to product safety.
 Excellent technical writing and documentation skills for regulatory submissions and

investigation reports.
 High attention to data integrity, documentation accuracy, and audit readiness.
 Ability to manage multiple priorities and regulatory deadlines in a high-volume complaint

environment.
 Strong cross-functional collaboration skills, with the ability to interact with Quality,

Regulatory Affairs, Manufacturing, Medical Affairs, and client stakeholders

📌 DHF Remediation (India)
🏢 Syrma Johari MedTech
📍 India