Product Complaint Analyst III

About the role

The Product Analyst III operates in a fast-paced, evolving, and dynamic environment, analyzing customer feedback to support complaint determination. This role utilizes Hazard Analysis (HA) and Design Failure Mode and Effects Analysis (DFMEA) to review and process Complaint Management Center (CMC) decision rationale statements. The Product Analyst III performs good faith efforts and coordinates activities with internal teams, field personnel, and end-use customers. As a Product Analyst III, you’ll write Medical Device Reports (MDR) and Medical Device Vigilance (MDV) regulatory submissions for the Urology Complaint Management Center (CMC). Additionally, you will communicate event investigation results through regulatory reports and other written communications, as appropriate.

Products within scope include Men’s Prosthetic Urology, Prostate Health, and Surgical Lasers.

As a Product Analyst III you’ll ensure compliance with Good Manufacturing Practices (GMPs), divisional Standard Operating Procedures (SOPs), Work Instructions (WIs), and proper complaint handling in accordance with 21 CFR Part 820, EU MDR, MDSAP, ISO 13485, and other applicable regulatory requirements.

Responsibilities

• Will perform thorough review of regulatory assessment, MDR/MDV and will provide complaint owners with feedback per CMC SOPs and WI.
• Will review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
• Will apply clinical knowledge, as related to product application, to evaluate identified complaints.
• Will investigate complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis.
• Will establish regulatory reportability decisions using HA, DFMEA, reported event, investigation and regulatory decision models.
• Will author Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
• Will apply codes to events to facilitate product performance records.
• Will review coding and investigations with engineering, laboratory, and other internal staff.
• Will compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.
• Will collaborate on new ideas and when needed participate in divisional improvement projects.
• Will provide support in the following areas: subject matter experts for divisional products, audit readiness, NCEP/CAPA investigation and ownership.
• Will collaborate on new ideas and when needed participate in divisional improvement projects.

Requirements

• Minimum of a Bachelor’s degree
• Minimum of 3 years of experience in medical device complaint handling
• Prior complaint handling experience for urological or laser devices
• Proficiency in a second language
• Proficiency with SAS, PowerBI, or TrackWise applications
• Experienced working collaboratively with cross-functional and global partners