Medical Associate

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:

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.