Posted:13 hours ago|
Platform:
On-site
Full Time
Minimum Qualification: Degree in Biomedical Engineering / Biotechnology / Life Sciences. Preferred / Advanced Master’s Degree (MSc, MBA with QA focus, or Regulatory Affairs). Requirements and skills: Must have Technical & Regulatory Knowledge. Quality & Compliance along with Technical skills. Communication, Critical Thinking, Organizational, Attention to Detail. Work Experience: 2–5 years in quality or regulatory affairs in a healthcare segment. Experience with FDA or ISO inspections/audits. Work Profile: Regulatory Compliance - QA systems must align with regional and international regulations (ISO, FDA etc) Quality Management System - Document and record control, management responsibility, internal audits, corrective and preventive actions, risk management. Design and Development Controls - Design planning, input/output verification, validation, review, history file. Process Control - Process validation, inspection, maintenance, traceability of final product. Complaint Handling and Market Surveillance - Collecting, reviewing, and responding to customer complaints, field safety corrective actions and recalls, clinical follow-up. Training and Competence - Maintain up-to-date training records, periodically reassess competencies. Risk Management. Job Types: Full-time, Permanent Pay: ₹10,109.64 - ₹34,105.43 per month Benefits: Leave encashment Provident Fund Schedule: Day shift Work Location: In person Application Deadline: 12/07/2025 Expected Start Date: 14/07/2025
Nidek Medical India
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