Looking to build a career in medical device regulatory affairs and post market surveillance (PMS)? Here’s a high-impact opportunity at Intuitive, a global leader in robotic-assisted surgery.
The Post Market Surveillance Analyst job in Bengaluru offers professionals a chance to work at the intersection of regulatory compliance, quality systems, and medical device safety, ensuring global patient safety and product performance.
🚀 About the Company – Intuitive
Intuitive is a pioneer in robotic-assisted minimally invasive surgery, known for innovations like the da Vinci surgical system. With a strong focus on patient outcomes and precision healthcare, the company operates globally across cutting-edge medical technologies.
📌 Job Overview
- Role: Post Market Surveillance Analyst
- Location: Bengaluru, India
- Department: Manufacturing & Operations
- Experience Required: 4+ years
- Industry: Medical Devices / Regulatory Affairs / Quality
🧪 Key Responsibilities
The Post Market Surveillance Analyst will play a critical role in managing medical device complaint handling and regulatory reporting:
- Perform complaint classification and triage based on regulatory requirements
- Conduct follow-ups with customers to gather investigation data
- Evaluate complaints for global regulatory reporting (FDA, EU MDR, etc.)
- Analyze device-related adverse events and determine root cause
- Apply IMDRF coding (Hazard, Harm, Severity) accurately
- Collaborate with quality, engineering, and regulatory teams
- Review and approve final complaint closure documentation
- Participate in regulatory compliance training and process improvement
🎓 Qualifications & Skills
🎯 Educational Requirements:
- Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
💼 Experience:
- Minimum 4+ years in medical device industry
- Hands-on experience in:
- Post Market Surveillance (PMS)
- Complaint handling systems
- Regulatory reporting (US FDA, EU MDR)
🧠 Key Skills:
- Strong understanding of quality systems and regulatory compliance
- Experience with risk assessment & complaint investigation
- Excellent technical writing and communication skills
- Proficiency in MS Excel, Word, PowerPoint, databases
- Ability to work in cross-functional teams and fast-paced environments
💰 Salary & Benefits (Estimated)
- Salary Range: ₹8 LPA – ₹14 LPA
- Additional Benefits:
- Exposure to global regulatory frameworks
- Work on advanced surgical technologies
- Career growth in Regulatory Affairs & Medical Devices
- Collaborative and innovation-driven environment
🌍 Why This Role is Important
Post Market Surveillance is a critical function in the medical device lifecycle, ensuring:
- Continuous patient safety monitoring
- Compliance with global regulatory standards
- Improvement in product quality and performance
This role directly contributes to real-world healthcare outcomes, making it highly impactful.
📩 How to Apply
