Job Opportunity: Post Market Surveillance Analyst – Intuitive

Job Summary
Intuitive, a global leader in robotic-assisted surgery, is seeking a detail-oriented and experienced Post Market Surveillance (PMS) Analyst to join our team in Bengaluru. In this role, you will be instrumental in ensuring the safety and performance of our world-class medical technologies by managing complaint handling and regulatory reporting processes. This is an ideal position for a regulatory affairs professional looking to make a significant impact on global patient outcomes within a high-growth, innovation-driven environment.

About Intuitive

Intuitive is the pioneer of robotic-assisted, minimally invasive surgery. Our flagship da Vinci surgical system has transformed the landscape of modern medicine, enabling surgeons to perform complex procedures with unparalleled precision. We are dedicated to improving patient outcomes through continuous innovation and a rigorous commitment to quality and safety.

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

As a PMS Analyst, you will serve as a vital link between our products and regulatory compliance. Your primary responsibilities will include:

• Complaint Management: Perform systematic classification and triage of product complaints according to internal and global regulatory requirements.
• Data Investigation: Conduct thorough follow-ups with customers to gather necessary investigation data and perform root-cause analysis for adverse events.
• Regulatory Reporting: Evaluate complaints to determine reportability to global health authorities, including the US FDA and under EU MDR guidelines.
• Coding & Documentation: Apply IMDRF coding (including Hazard, Harm, and Severity) with high accuracy and review/approve final complaint closure documentation.
• Cross-Functional Collaboration: Partner closely with quality, engineering, and regulatory affairs teams to ensure consistent adherence to safety protocols.
• Continuous Improvement: Participate in regulatory compliance training and contribute to process improvement initiatives to streamline surveillance operations.

Qualifications & Skills

Educational Requirements:

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or a related field.

Professional Experience:

• A minimum of 4+ years of professional experience within the medical device industry.
• Demonstrated hands-on experience in Post Market Surveillance (PMS), complaint handling systems, and global regulatory reporting (US FDA, EU MDR).

Key Skills:

• Comprehensive knowledge of quality management systems and medical device regulatory standards.
• Proven ability in risk assessment, technical writing, and complaint investigation.
• Exceptional communication skills and the ability to work effectively within cross-functional, fast-paced teams.
• High proficiency in MS Office (Excel, Word, PowerPoint) and various internal databases.

Benefits

• Competitive Compensation: Estimated salary range of ₹8 LPA – ₹14 LPA, commensurate with experience.
• Global Exposure: Gain invaluable experience working with international regulatory frameworks and diverse global teams.
• Innovative Environment: Contribute to the development and safety of cutting-edge surgical technologies that change lives.
• Career Growth: Access to professional development opportunities within the specialized field of Regulatory Affairs and Medical Devices.
• Impactful Work: Join a culture that prioritizes patient safety and continuous product improvement, knowing that your work directly supports real-world healthcare outcomes.

How to Apply

If you are a dedicated professional passionate about medical device safety and regulatory excellence, we invite you to apply for this position. Please submit your application via the official Intuitive careers portal to be considered for this role.

[Click here to view the full job description and submit your application on the Intuitive Careers page.]