Compliance Analyst II

Job Description

Job Summary:

• The COMPLAINT VIGILANCE ANALYST II is responsible for processing product quality complaints and supporting day-to-day activities for complaint management for the North America region and globally (as needed).

Duties and Responsibilities:

• Conduct initial assessment and identification of complaints in alignment with the product quality complaint program.
• This may include, but is not limited to, review of complaints to verify customer verbatim, lot number, subject coding, and trend analysis.
• Analyze complaint data for timely processing and investigation of complaints related to product quality issues.
• Review and process updated information for complaint change logs from the call center and medical safety to assess impact on triage and investigation process.
• Collaborate with cross-functional teams such as Global Consumer Care, Medical Safety Internal affiliates and External site representatives to address and resolve complaints efficiently.
• Monitor complaint records in the complaint management system to ensure standard process is being followed and complaints are closed as required.
• Prepare reports as requested in support of internal and external audits as needed.
• Compiles product and lot-specific complaint trending data and complaint closure metrics as requested.
• Assist with global and regional projects within the department, communicate effectively with all levels of management.
• Assist with/participate in various projects and activities related to Complaint Vigilance process and system implementations and improvements.
• Support identification of continuous improvement activities.
• As necessary, this position will support the Analyst functions in other Geographical regions for Consumer products.
• Detail-oriented with the ability to document and track corrective actions and complaint investigations.
• Proficiency in the use of computer systems and applications such as Microsoft Office Suite.

Requirements:

• Strong analytical skills with the ability to interpret complex data effectively.
• Experience with data analysis and reporting tools, with a focus on identifying trends and insights.
• Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
• Ability to adapt to changing priorities and work effectively in a fast-paced environment.
• Demonstrated ability to work as part of a team to achieve organizational goals.
• Knowledge of regulatory requirements and quality assurance processes in the healthcare industry.

Language Requirement:

• Local and English (effectively writing & speaking).