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.

Essential Job Duties

Investigating complaints daily:

Perform the preliminary classification of complaints and escalation complaints that require additional review.

Perform Failure Analysis investigation review and escalation 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

Strong computer skills (Excel, Word, PowerPoint, database)

Efficient independent worker with ability to focus

Attention to detail

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

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📌 Post Market Surveillance Specialist (Centro Cívico)
🏢 Intuitive Surgical, S. De R. L De C. V.
📍 Centro Cívico