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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