Post Market Surveillance Adverse Event Analyst

Primary Function of Position:

The Regulatory Post Market Surveillance Adverse Event Analyst investigates customer complaints related to injury / adverse event / or death cases and makes reporting decisions, files regulatory reports, and ensures completeness and consistency of complaint documentation. This role includes live telephone intake and documentation of death and injury events phoned in to Intuitive by company representatives and customers.

Roles & Responsibilities:

• Investigating serious injury / adverse event and death complaints daily
• Perform the preliminary classification of complaints including reportability triage and decision making
• Conduct complaint investigations including following up with surgeons and other health care professionals via phone and email
• Perform reportability determinations in conjunction with medical safety officer, as necessary
• Provide input to clinical conclusion to be included in the complaint file and regulatory reports
• Escalate complaints that require additional review to engineering, medical safety officer, clinical development engineering, etc.
• Accurately select Risk (Hazard, Harms, Severity) and IMDRF codes
• Review product analysis investigation and determine cause / contribution of event to device
• Draft and file medical device and vigilance Reports
• Evaluate documentation for completeness and consistencyApprove final complaint file for closure after all applicable actions are completed
• Manage complaint workload to required timeliness and goals
• Collaborate with internal teams including clinical development engineering, human factors, medical safety office, risk management, engineering, and other departments as needed to provide relevant and critical clinical information related to adverse events

Education

Degree in life science (e.g. RN), engineering, or equivalent.

Advanced English proficiency, both written and spoken.

Experience

Minimum 5+ years of experience in medical device field, with experience in the following areas:

• Working knowledge and understanding of the FDA 21 CFR part 803 Medical Device Reporting and part 820.198 for Complaint File management
• Global regulatory medical device requirements for EU, MDSAP countries, and other related requirements

Skills

The following skills are required for this position:

• Demonstrate strong written and verbal communication skills
• Strong computer skills (Excel, Word, PowerPoint, database query)
• Efficient independent worker with ability to focus
• Attention to detail
• Demonstrate cross functional communication skills in email and in person
• Strong analytical and Excellent organizational skills
• Ability to handle and manage workload independently
• Prioritize numerous activities in a rapid paced environment
• Contribute to team-oriented tasks
• Strong interpersonal and decision‑making skills

Competency / Training

The following competencies are essential for this position:

• Firm understanding of Regulatory reporting requirements for Medical Devices and complaint system and process requirements including good documentation practices and quality system elements.
• Firm understanding of quality records requirements and how they apply to complaint files.
• Familiarity with world‑wide regulatory reporting requirements.
• Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.