Regulatory Post-Market Analyst — Medical Devices (Onsite)

Intuitive; Mexicali; On-site; MXN 350,000 - 520,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, is seeking a Regulatory Post Market Surveillance Specialist. The role focuses on investigating customer complaints, performing failure analyses, and ensuring complete documentation to meet regulatory requirements.

The position involves coordinating with Customer Service and hospitals, escalating issues when new failure modes are found, and contributing to process improvements within a fully onsite work environment.

Qualifications

• Education - degree in engineering, life science, or equivalent.
• Advanced English proficiency, both written and spoken.
• 2+ years of experience in medical device field.

Responsibilities

• Investigate customer complaints and make initial reporting decisions.
• Provide failure analysis letters and ensure documentation completeness.
• Classify complaints and escalate as needed.
• File malfunction MDR reports and escalate adverse events or incidents.
• Evaluate documentation for completeness and assign actions to close files.
• Approve final complaint files for closure after actions are completed.
• Manage complaint workload to backlog goals.
• Review lot documentation to identify anomalies related to failures.
• Escalate to appropriate managers or PMI group when needed.
• Ensure regulatory reporting requirements are met and interface with Customer Service.
• Create customer response letters and provide peer review.

Skills

Advanced English

Written communication

Analytical skills

Education

Bachelor's degree in engineering, life sciences, or equivalent

Job description

Intuitive, a global leader in robotic-assisted surgery, is seeking a Regulatory Post Market Surveillance Specialist. The role focuses on investigating customer complaints, performing failure analyses, and ensuring complete documentation to meet regulatory requirements.

The position involves coordinating with Customer Service and hospitals, escalating issues when new failure modes are found, and contributing to process improvements within a fully onsite work environment.