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 & Responsibilities
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:
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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
Qualifications
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
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Wipro is committed to creating an accessible, supportive, and inclusive workplace. Reasonable accommodation will be provided to all applicants including persons with disabilities, throughout the recruitment and selection process. Accommodations must be communicated in advance of the application, where possible, and will be reviewed on an individual basis. Wipro provides equal opportunities to all and values diversity.