Pharmacovigilance Post Market Surveillance Analyst – Intuitive, Bengaluru
- Company Overview
- Job Role & Responsibilities
- Complaint Intake & Evaluation
- Regulatory Review & Reporting
- Documentation & Quality Compliance
- Cross‑Functional Collaboration
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Summary Table
- FAQs
Post Market Surveillance Analyst – Intuitive, Bengaluru
Apply for Post Market Surveillance Analyst at Intuitive, Bengaluru. Medical device complaint handling role for experienced life science professionals.
Intuitive is expanding its post‑market quality and regulatory team in Bengaluru, offering an opportunity for experienced professionals to support global medical device safety, compliance, and product performance. This role suits individuals who understand medical device complaint handling and want to contribute to patient safety in a fast‑paced, innovation‑driven environment.
Company Overview
Intuitive is a global leader in robotic‑assisted surgery and minimally invasive care. For over two decades, the company has advanced technology that helps clinicians deliver safer, more precise treatment. With a strong commitment to quality, regulatory excellence, and patient outcomes, Intuitive invests heavily in research, innovation, and workforce development. The Bengaluru site plays a key role in supporting global post‑market surveillance and regulatory compliance.
Job Role & Responsibilities
The Post Market Surveillance Analyst supports global complaint handling activities and ensures compliance with regulatory reporting requirements. Responsibilities include:
Complaint Intake & Evaluation
- Perform preliminary complaint classification and escalate events requiring deeper investigation.
- Conduct follow‑ups with customers or reporters through calls and email to gather missing information.
- Retrieve RMAs and coordinate with relevant teams for sample evaluation.
Regulatory Review & Reporting
- Assess complaints for global regulatory reporting according to internal procedures and international requirements.
- Determine IMDRF codes, hazard categories, severity, and risk attributes.
- Evaluate product analysis findings and identify event contribution and device relationship.
Documentation & Quality Compliance
- Review case files for completeness, accuracy, and regulatory readiness.
- Approve final complaint files after all investigations and corrective actions are complete.
- Participate in ongoing regulatory compliance training and maintain high-quality documentation standards.
Cross‑Functional Collaboration
- Work with Clinical Engineering, Field Service, Technical Support, Failure Analysis Engineering, and Risk Management teams.
- Support field action assessments and regulatory responses where required.
- Contribute to process improvement initiatives and continuous quality enhancement.
Eligibility / Qualifications
Education:
- Bachelor’s degree in Engineering, Life Sciences, or equivalent discipline.
Experience:
- Minimum 4 years of experience in medical devices with strong exposure to post‑market surveillance and complaint handling.
Technical Skills:
- Knowledge of global regulatory reporting requirements (US FDA, EU MDR).
- Experience with complaint management systems and quality records.
- Proficient in MS Office and database tools.
- Strong analytical, documentation, and communication skills.
Other Requirements:
- Ability to prioritize workload and manage cases independently.
- Strong understanding of medical device workflows, terminology, and risk assessment.
- Detail‑oriented, structured, and able to work cross‑functionally.
Location & Salary
Location: Bengaluru, Karnataka (On‑site)
Compensation: Competitive salary and benefits aligned with Intuitive’s global standards. The company offers performance‑linked incentives, comprehensive health coverage, and career‑development programs.
Application Process
Interested candidates can apply directly through Intuitive’s careers portal:
Apply Here: https://careers.intuitive.com/en/jobs/744000097526010/REF24148J/post-market-surveillance-analyst/
Summary Table
| Company | Intuitive Surgical |
| Vacancies | Multiple openings |
| Required Education | Bachelor’s in Engineering, Life Sciences, or related |
| Experience | 4+ years in medical device complaint handling |
FAQs
1. What experience is required for this role?
A minimum of four years in medical device complaint handling, post‑market surveillance, or regulatory affairs.
2. Are freshers eligible?
No. This position requires hands‑on experience with regulatory reporting and complaint processing.
3. Is this a remote role?
No. The position is on‑site in Bengaluru.
4. What teams does this role work with?
Clinical Engineering, Technical Support, Field Service, Failure Analysis, Regulatory, and Risk Management.
5. What regulatory knowledge is required?
Understanding of global reporting requirements including FDA, EU MDR, IMDRF coding, and medical device quality systems.
To apply for this job please visit careers.intuitive.com.
