Product Complaint Associate

STAAR Surgical is a company focused on ophthalmic products, and they are seeking a Product Complaint Associate to manage and investigate product complaints. The role involves coordinating with various departments to ensure compliance with regulations and maintaining accurate documentation of complaints and investigations.

Responsibilities

• Act as consolidation point for receiving, processing, investigating and reporting product complaints
• Coordinate and/or perform the evaluation, investigation, follow-up and documentation of all STAAR product complaints. Maintain complaint files
• Coordinate complaint investigations according to complaint handling procedures, which includes but is not limited to:
• Interface with physicians and/or health care professionals regarding information relevant to the product complaint
• Interface and coordinate with Regulatory, Quality, Clinical Affairs and Medical Affairs to conduct investigations, risk assessments and determine reporting requirements
• Perform prompt handling of complaints, including identification and evaluation of device product complaints for potential reportable adverse event according to procedures
• Inform management responsible for complaint handling when information in a complaint suggests that action may be required to prevent unreasonable risk of substantial harm to the public, that there is an indication of a trend or that there are unusual adverse events
• Ensure incident reports (e.g. Medical Device Reports, Health Canada Reports, Vigilance reports, etc.) are submitted in compliance with respective regulations (e.g. U.S. FDA Regulations, Canadian Medical Device Regulations, MDD/MDR, MDSAP, etc.)
• Ensure accuracy, integrity, completeness and consistent content of product complaint reports, investigations, incident reports, in the complaint files and electronic complaint database
• Support external (e.g. FDA, DEKRA, etc.) and internal audits as required
• Provide support, as required for other aspects of the post-market surveillance system (i.e., data analysis of complaint reports, files and adverse event reporting logs)
• Provide support for medical affairs activities, as requested
• Other duties as assigned

Skills

• High School graduate or equivalent required
• Demonstrated understanding of, and ability to interpret, regulations and guidelines governing medical device manufacturing, including but not limited to, CFRs, ISO 13485, MDD, CMDR, MDSAP, MDR
• Proficiency in MS Word and Excel
• Ability to work well within a team and interdepartmentally
• Special competencies: timely and quality decision making; well-developed organizational ability, time management reasoning and problem-solving skills
• Good communication skills, written and verbal
• Associate's Degree or higher desired
• 1 year's ophthalmic experience, or equivalent combination of education and experience, preferred
• 3 years' experience in FDA regulated industry preferred; experience handling complaints and medical device reporting is highly desirable

Company Overview

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