Complaint Vigilance Investigator II

Intuvie; Natick (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Intuvie is seeking a Complaint Vigilance Investigator II to manage the full complaint lifecycle, from feedback review to regulatory reporting. You will collaborate with Service, Customer Service, Quality, Regulatory and Engineering teams to ensure accurate coding, MDR initiation, and comprehensive investigations.

Minimum 2–4 years in FDA-regulated complaint handling, with strong data analysis and communication skills required.

Qualifications

• 2-4 years complaint handling experience, preferably in FDA-regulated environment for medical device industry.
• Accurate attention to detail and thoroughness.
• Ability to learn infusion product operations and testing procedures.
• Knowledge of 21 CFR 820 and MDR filing processes and FDA requirements.
• Strong communication and data analysis skills.
• Team player and independent contributor.

Responsibilities

• Review and analyze all feedback and assess if a complaint is alleged.
• Triage customer feedback or questions and initiate complaints into the database.
• Execute initial complaint review to ensure accurate codes are assigned, GFE are initiated, and intake has been properly performed.
• Conduct thorough investigations into customer complaints, adhering to regulatory guidelines.
• Perform final complaint review to ensure all requirements to investigate a complaint are met.
• Provide feedback to improve Complaint and MDR processes.
• Collaborate with Customer Service and Operations teams to facilitate the complaint handling process.
• Reach out to the complainant to obtain missing information needed for the investigation and MDR processes; provide response letters when requested.
• Initiate and process MDR filings for the FDA; attend MDR review meetings for coding and narrative guidance.
• Document all stages of customer complaints with accurate records for compliance.
• Apply analytical skills and product knowledge to evaluate complex situations using multiple sources.
• Escalate to Management potential safety issues or impediments to close records.
• Support process improvements to complaint handling and MDR processes.
• Support metrics and reports from the complaint handling system.
• Identify potential concerns and escalate to management when necessary.
• Provide support of CAPAs and NCs as necessary.
• Train to SOPs, WI and templates/forms.

Skills

Complaint handling

Regulatory reporting

Data analysis

Team collaboration

Job description

As a Complaint Vigilance Investigator II, you will play a pivotal role in the complaint handling process. Your responsibilities will encompass all stages of the complaint lifecycle, from feedback review to the completion of regulatory decision trees, with focus on complaint investigation and regulatory reporting. This position works closely with the Service, Customer Service, Quality, Regulatory and Engineering Teams.

ESSENTIAL JOB FUNCTIONS

• Review and analyze all feedback and assess if a complaint is alleged.
• Triage customer feedback or questions and initiate complaints into the database.
• Execute initial complaint review to ensure accurate codes are assigned, GFE are initiated, and intake has been properly performed.
• Conduct thorough investigations into customer complaints, adhering to regulatory guidelines.
• Perform final complaint review to ensure all requirements to investigate a complaint are met.
• Provide feedback to improve Complaint and MDR processes.
• Collaborate with Customer Service and Operations teams to facilitate the complaint handling process.
• Reach out to the complainant to obtain missing information (GFE’s) needed for the complaint investigation and/or MDR processes. Provide customer response letters when requested.
• Initiate and process MDR filings for the FDA, demonstrating a comprehensive understanding of regulatory requirements. Attend MDR review meetings for coding and narrative guidance on MDRs.
• Document all stages of customer complaints, maintaining accurate records for compliance purposes.
• Applies analytical skills and product knowledge to evaluate complex situations using multiple sources of information
• Escalation to Management of potential safety issues or issues that could impede the ability to process complaints and close records.

OTHER DUTIES AND RESPONSIBILITIES

• Support process improvements to the complaint handling and MDR processes
• Support metric and reports from the complaint handling system
• Identifies potential concerns and escalates to management when necessary
• Provides support of CAPAs and NC’s as necessary
• Train to all assigned SOP’s, WI and templates/forms
• Additional responsibilities may or may not be assigned to the employee; role assignment will be reviewed on a case-by-case basis determinant upon individual strengths, experience, knowledge, and expertise.

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES

• Minimum 2-4 years complaint handling experience required: Preferred in the FDA-regulated environment for Medical Device industry.
• Accuracy, attention to detail, and thoroughness required
• Ability to learn the basic operation and testing procedures for infusion products
• Knowledge of 21CFR 820 Quality System Regulations and familiarity with MDR filing processes and requirements for the FDA as per 21CFR820 and 21CFR803.
• Strong communication and data analysis skills.
• Team player as well as an individual contributor that can work independently to achieve goals.

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal business office environment. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.