Post Market Surveillance Specialist

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

• Ways of Working: Onsite - This job is fully onsite.
• Employee Type: Employee
• Global Job Level (HCM): Professional 2 (7)

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.

We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.

If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.

Job Description

Primary Function of Position
The Regulatory Post Market Surveillance Specialist investigates customer complaints, makes an initial reporting decision, provides failure analysis letters, and ensures completeness and consistency of complaint and related documentation.

• Perform the preliminary classification of complaints and escalates complaints that require additional review.
• Perform Failure Analysis investigation review and escalates complaints that require additional review.
• File Malfunction MDR Reports as identified
• Escalate Adverse Event or Incident reports to Level IV Analysts as identified
• Evaluate documentation for completeness and consistency and assign additional actions as necessary to close the complaint file.
• Approve final complaint file for closure after all applicable actions are completed.
• Manage complaint workload to required backlog goals.
• Review and analyze lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.
• Escalate complaints to the Regulatory Post Market Surveillance Manager or Lead when new failure modes are encountered
• Escalate complaints to the Post Market Investigation (PMI) group as required
• Evaluate complaints for reporting requirements in accordance with company procedures and Regulatory requirements.
• Interface with Customer Service and hospitals to gather additional information required for complaint investigation, including retrieval of RMA
• Create customer response letters
• Provide peer review and feedback of complaints and reports
• Participate in new hire training and continuous Regulatory Compliance training as required
• Participate in process improvement activities to continuously improve process effectiveness

Qualifications

Required Education and Training

Education - degree in engineering, life science, or equivalent

Advanced English proficiency, both written and spoken.

Experience – 2+ years of experience in medical device field, with experience or exposure in the following areas:

• Knowledge and understanding with Medical Device Complaint files and quality record documentation
• Knowledge and understanding of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
• General technical and or clinical medical device knowledge

Working Conditions

• None

Preferred Skills and Experience

• Demonstrate strong written and verbal communication skills
• Efficient independent worker with ability to focus
• Demonstrate cross functional communication skills in email and in person
• Excellent organizational and analytical skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team-oriented tasks
• Strong analytical skills
• Strong interpersonal and decision-making skills
• General understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements
• General understanding of quality records requirements and how they apply to complaint files
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary

Additional Information

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