Qline Biotech Hiring For Quality Assurance / Regulatory Affairs

Are you experienced in IVD post-market surveillance, complaint handling, and regulatory reporting? Qline Biotech is hiring a Complaint Handling & PMS Specialist to strengthen its global Quality Assurance & Regulatory Affairs operations. This role is ideal for professionals passionate about patient safety, compliance, and continuous product improvement aligned with MDR 2017, EU IVDR, ISO 13485, and FDA QSR.

🔍 Key Responsibilities

1. Complaint & Adverse Event Handling

• Investigate product complaints for IVD devices.
• Report adverse events to CDSCO (MvPI), EU authorities, and US FDA.
• Maintain complaint logs and ensure timely closure with CAPA.

2. Recall & Field Action Management

• Coordinate product recalls and Field Safety Corrective Actions (FSCA).
• Prepare documentation and correspond with regulatory bodies.

3. Risk Management

• Update and maintain risk files based on PMS data.
• Support risk assessments following ISO 14971.

4. QMS & eQMS Operations

• Work on Windchill or similar eQMS platforms for complaint tracking.
• Maintain documentation aligned with ISO 13485, MDR 2017, EU IVDR, and FDA 21 CFR Part 820.

5. Dashboarding & Reporting

• Create dashboards for complaints, CAPA, recalls, and trends.
• Use Excel or Power BI for PMS analytics.

6. Training & Cross-Functional Collaboration

• Train teams on complaint handling and PMS procedures.
• Collaborate with QA, RA, Production, and Customer Service departments.

🎯 Eligibility & Ideal Candidate Profile

• Bachelor’s/Master’s in Life Sciences, Biomedical Engineering, or related field.
• 2–5 years experience in PMS for IVD or medical devices.
• Strong knowledge of CDSCO MDR 2017, EU IVDR, FDA QSR.
• Experience with Windchill or equivalent eQMS tools.
• Excellent documentation and communication skills.

🏅 Preferred Certifications

• Certified Quality Auditor (CQA) or equivalent.
• Training in ISO 14971, adverse event reporting, and eQMS platforms.

💼 Benefits of Joining

• Opportunity to work on global-market IVD products.
• Exposure to international regulatory frameworks.
• Growth path in Quality & Regulatory Affairs.
• Collaborative work environment focused on innovation & patient safety.

📩 How to Apply

Send your resume and cover letter to:
📧 mehak.chauhan@qlinebiotech.com