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Product Surveillance Specialist

2 months ago

Clearwater, United States Bausch + Lomb Full time
Job Summary

Bausch + Lomb is a leading global eye health company seeking a highly skilled Product Surveillance Specialist to support our medical device compliance efforts. As a key member of our team, you will be responsible for managing communication between manufacturers, distributors, and regulatory authorities for all medical device complaint-related activities.

Key Responsibilities
  • Provide expert analysis and management of information regarding medical device complaint events and/or adverse events, including follow-up, case processing, and assessment for post-marketing activities.
  • Communicate with physicians, staff, and/or patients to obtain pertinent complaint information.
  • Evaluate and engage appropriate management for critical and/or unusual events.
  • Liaise with internal functions (Quality, Regulatory, Medical Affairs, Customer Service, Manufacturing, and R&D) to gather critical input into medical device event reports.
  • Review complaint manufacturing investigation reports and provide comments in accordance with procedures.
  • Perform and/or document regulatory reportability decisions on complaints in accordance with applicable local laws and regulations.
  • Codes complaints and adverse events using IMDRF adverse event terminologies (terms and codes).
  • Ensure complaints are processed in a timely manner.
  • Review and close complaint files.
  • Communicate with local and international competent authorities, including generation and/or submission of medical device event reports as required by applicable local laws and regulations.
  • Assist local affiliates with the preparation and submission of medical device complaints and/or incident reports, when required.
  • Participate in preparation for Notified Body audits and/or Competent Authority inspections.
  • Support root cause investigations and participate in CAPA (Corrective and Preventive Action) activities.
  • Support complaint handling trending activities and complaint data requests.
  • Perform all other duties as assigned.
Requirements
  • BS/BA degree or AAS degree with relevant experience in medical device case management.
  • Knowledge of ophthalmic medical terms, medical device reporting regulations, GMPs for medical devices preferred.
  • Strong written, oral, and listening communication skills to interact with customers and other professionals.
  • Ability to generate and organize clear, concise responses when communicating with various levels of management.
  • Superior organizational skills to manage challenging deadlines.
  • Ability to adjust to change with minimal or no interruption.
  • Recognize problems and suggest applicable solutions.
  • Able to perform job function with minimal supervision and make independent decisions, where appropriate.
  • Proficient in the use of personal computers, including database management and word processing.