Job Description

Role Purpose

The purpose of the role is to provide effective technical support to the process and actively resolve client issues directly or through timely escalation to meet process SLAs

Roles & Responsibilities͏

Owns the complaint handling process including  

Complaint evaluation including adverse event reporting decisions, coding, follow up for additional information and closure of records 

Initiating Good Faith Effort (GFE) and Follow-ups for additional information and product returns 

Assessment of Complaints (events) for proposed MDR reportability and submits assessment to client and/or submits directly to the regulatory authority   

Owns the complaint investigation activities including: 

Assessment of the accuracy of the hazard code assigned to the record 

Run the decision tree based on the information available in the complaint record 

Reportability assessment 

Complete good faith effort for missing information (NR) 

Failure code assignments (NR) 

Risk Level Assignment(NR) 

Complaint Review and Closure 

Assesses cases to determine if event meets Philips’ complaint criteria and escalates to Philips is required  

Performs reviews and assessments of complaints processed by peers as part of cross utilization approach 

Responsible for contacting SME’s, QAs, Team Lead as needed to obtain complaint closure 

Responsible in timely escalation of significant events to the Team Lead 

Keeps oneself updated, aware of, and compliant to all Company and Customer policies and procedures which include Information Security Management Systems 

Keeps all company information which includes customer information confidential and secured 

Qualifications͏

Registered Nurse with License with minimum 0 - 1 years of experience 

Registered Nurse with License with 1+ years of experience in a medical device or regulated industry preferred 

Mandatory Skills

Has basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001 

Able to write effective Medical and Technical narratives regarding the complaints 

Able to create Customer Letters, if required 

Must have good computer skills, effective keyboarding skills 

Must have excellent telephonic and listening skills 

Able to think critically to determine the type of questions which need to be asked to gather necessary information 

Good problem solving and analytical skills 

Good customer service skills