Associate I, Complaints
Core
Process and investigate product defect complaints, ensure regulatory compliance, and collaborate with cross-functional teams to drive problem-solving and continuous improvement in quality and regulatory affairs.
Role type
Associate I, Complaints (Quality & Regulatory Affairs)
Builds
Product defect investigation reports, regulatory submissions, and unified operating procedures
Domain
Medical devices / Ophthalmic products / Quality & Regulatory Compliance
Required skills
Product complaint investigation, regulatory compliance (GxP), documentation management, cross-functional collaboration, process improvement, data analysis, SOP adherence, adverse event reporting
Preferred skills
None stated
Technologies
None stated
Responsibilities
Process and investigate product defect complaints; Monitor trending and reporting of product defects; Collaborate with Medical Safety and R&D on adverse events; Ensure compliance with regulatory agency reporting requirements; Support complaint activity monitoring and suggest process modifications; Maintain accurate and complete documentation
Seniority
Entry-level (Associate I), hands-on IC