Job Summary

Responsible for assuring timely case/complaint review and assignment. Responsible for asurng the escalation of potentially reportable com­plaints with attention to country specific reporting timelines. Re­sponsible for reviewing complaints for accuracy and timely risk re­view. Responsible for monitoring the inquiry system. Responsible for assuring streamlined and efficient systems for complaint resolution. Re­sponsible for product family specific sytems and documentation which contribute to an effective complaint system compliant with FDA, ISO and Worldwide standards.

Key Accountabilities

• Ensures timely and thorough review of all complaints and inquiries, prioritizing potentially reportable events.
• Escalate any potentially reportable complaint or inquiry, communi­cates with the crossfunctional team and management, drives the post market Risk Analysis Worksheet (RAW) process through completion.
• Communicates updates on escalations, priorities, and complaint status to leadership and in various meetings.
• Chairing meetings and providing guidance and direction to the RAW team.
• Trains and develops subordinates, as appropriate, to achieve duties and responsibili­ties.
• Coordinates and/or attends meetings with appropriate departments for specific customer complaint issues, determination and resolution of root causes for complaints.
• Analyze post market data for trends, ensure necessary escalations, investigations and CAPA actions are taken to remediate negative trends.
• Responsible for maintaining Complaint KPI data and reporting as necessary.
• Responsible for gathering complaint and RAW data for Post Market Surveillance and updating the RA reports including assessing newly identifed risks.
• Follows regulatory requirements for complaint management.
• Establish and maintain a system to review literature and social media for complaints
• Manages tasks supporting complaint investigations, including returned parts and ex­ternal assignments.
• Supports investigation activities and provides guidance for resolving product mal­ functions.
• Will work cross-functionally to obtain information required to support regulatory and business decisions.
• Performs other related duties as assigned.

Networking/Key relationships

• Medical Affairs
• R&D
• Regulatory Affairs
  
• IT /Cybersecurity
  
• Global Affiliates
  
• Operations
  
• Other technology centers

Minimum Knowledge & Experience for the position:

• Bachelor's degree in relevant field (i.e. Life Science, Biochemistry, Engineering or similar
• Eight years (with a Bachelor's) or five years (with a Master's) relevant experience.
• Three to five years of supervisory or people management experience.

Skills & Capabilities:

• Strong knowledge of FDA, Medical Device and IVD regulations and quality systems related to complaints, and statistical techniques and the ability to train others re­lated to these requirements.
• Strong customer focus and continuous improvement mentality.
• Excellent written and oral communication skills
• Ability to drive Risk Management, escalation and complaint closure processes.
• Critical thinking skills, including the ability to analyze and trend data and communi­cate concerns as needed.

Travel requirements:
N/A