Post Market Surveillance Specialist

Intuitive; Mexicali; Presencial; MXN 350.000 - 550.000; Jornada completa

Descripción de la vacante

Intuitive in Mexico is seeking a Regulatory Post Market Surveillance Specialist to investigate and manage medical device complaints, perform failure analysis, and ensure regulatory reporting compliance.

You will classify complaints, file MDR reports, escalate issues, and collaborate with Customer Service and hospitals to gather information required for investigations. This role emphasizes thorough documentation, backlog management, and continuous process improvement.

Formación

• Education in engineering or life science; English proficiency required: 85% (spoken and written).
• 2+ years of experience in medical device field with knowledge of complaint files and quality record documentation.
• Knowledge of regulatory reporting requirements for Medical Devices (US FDA, EU MDD, etc.).

Responsabilidades

• Investigate customer complaints and provide failure analysis letters.
• Classify complaints and escalate as needed.
• File MDR reports and escalate to PMI as required.
• Review lot documentation for anomalies related to product failures.
• Interface with Customer Service and hospitals to gather information for investigations.
• Create customer response letters and participate in training and process improvements.

Conocimientos

Strong communication

Independent worker

Cross-functional collaboration

Analytical skills

Organizational skills

Decision making

Educación

Engineering or life science degree

Descripción del empleo

• 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 elevate complaints that require additional review.

Perform Failure Analysis investigation review and elevate 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
English proficiency required: 85% (spoken and written).

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.