Role & responsibilities
PREPARE, REVIEW, AND UPDATE TECHNICAL DOCUMENTATION, INCLUDING DEVICE DESCRIPTION.
DRAFT AND MAINTAIN TECHNICAL FILES FOR ALL MEDICAL DEVICES, ENSURING COMPLIANCE WITH ANNEX-II OF EU MDR 2017/745.
ENSURE ALL DOCUMENTATION MEETS REGULATORY REQUIREMENTS, INCLUDING SAFETY AND PERFORMANCE STANDARDS.
UPDATE TECHNICAL FILES AS NECESSARY FOR PRODUCT CHANGES IN PRODUCT DESIGN, MANUFACTURING PROCESSES, OR REGULATORY REQUIREMENTS.
WORK CLOSELY WITH R&D;, MANUFACTURING, QUALITY ASSURANCE, AND OTHER DEPARTMENTS TO GATHER NECESSARY INFORMATION AND ENSURE ACCURACY OF THE TECHNICAL DOCUMENTATION.
SUPPORT REGULATORY AUDITS AND INSPECTIONS BY PROVIDING NECESSARY DOCUMENTATION AND TECHNICAL FILE EVIDENCE.
STAY UPDATED WITH CHANGES IN EU MDR AND OTHER RELEVANT REGULATIONS.
IMPLEMENT NECESSARY CHANGES IN THE TECHNICAL DOCUMENTATION.
MAINTAIN ACCURATE RECORDS OF ALL VERSIONS OF THE TECHNICAL FILE AND ENSURE DOCUMENT CONTROL.

📌 Walk In Assistant Manager / Sr Engineer Quality Assurance Faridabad
🏢 Polymed
📍 Faridabad