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

P͏ersonal Responsibilities

• Owns the complaint evaluation 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 submit assessment to client and/or submit directly to the regulatory authority. 
• Initial reviews, duplicate checks, initial damage coding, Adverse event reporting decisions, follow up for additional information and closure of records.
• Clinical assessments
• For any breach of reporting timelines, ensure that proper root cause analysis is provided.

• 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.

S͏kills Required

• 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 telephone 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.

C͏andidate Specifications

• Graduate/Post Graduate of any of the Allied Life Sciences courses with minimum 0 - 1 years of experience or  Bachelor’s degree in bio medical engineering, or related technical degree with minimum 0 - 1 years of experience or Medical Device or biomedical experience in undergraduate program or other related work experience or

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Deliver