Post Market Surveillance Specialist

Intuitive Surgical, S. de R.L de C.V.; Mexicali; Presencial; MXN 260.000 - 380.000; Jornada completa

Descripción de la vacante

Intuitive Surgical, S. de R.L de C.V.

is seeking a Regulatory Post Market Surveillance Specialist in Mexicali to investigate customer complaints, classify issues, and coordinate failure analyses in accordance with US FDA and global medical device requirements. You will prepare complaint documentation, file MDR reports, escalate complex cases, and communicate with hospitals to obtain data while ensuring timely closure of files.

Formación

• Education - degree in engineering, life science, or equivalent.
• English proficiency required: 85% (spoken and written).
• Experience – 2+ years of experience in medical device field.

Responsabilidades

• Investigating complaints daily.

Conocimientos

Regulatory compliance

Medical device experience

Data analysis

Communication skills

Documentation

Excel

Cross-functional collaboration

Educación

Engineering or Life Science degree

Herramientas

Excel

PowerPoint

Database

Descripción del empleo

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