Medical Associate
3 weeks ago
Requisition ID: 20649
City: Cebu
Country/Region: PH
Job DescriptionRole 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.
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).
- Complaint review and closure:
- Assesses cases to determine if event meets Philips' complaint criteria and escalates to Philips if required.
- Performs reviews and assessments of complaints processed by peers as part of cross-utilization approach.
- Responsible for contacting SMEs, QAs, Team Lead as needed to obtain complaint closure.
- Responsible for 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.
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.
We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, caste, creed, religion, gender, marital status, age, ethnic and national origin, gender identity, gender expression, sexual orientation, political orientation, disability status, protected veteran status, or any other characteristic protected by law.
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.
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