Post Market Surveillance Specialist 1 at Fresenius Medical Care

Reynosa, Tamaulipas, Mexico

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's degree preferred, preferably in a healthcare related field
Minimum 2–5 years of related experience in the healthcare/device industry or exposure to medical device quality system regulations; understanding of drug/device safety requirements preferred; with an Advanced Degree no prior experience may be considered
Prior experience processing medical device or drug complaints preferred
Strong interpersonal skills
Knowledge based PC computer skills essential, such as industry recognized complaint management systems, crystal reporting, MS Access and Excel
Familiarity with medical terminology preferred
Bilingual (English/Spanish); fluent in English

Responsibilities

Developing professional expertise, applies company policies and procedures to resolve a variety of issues
Interfaces with Customer Service and customers/patients to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and/or durable equipment retrieval for evaluation
Ensures that complaints from multiple sources (i.e. email, phone, verbal, fax, etc.) are entered into the complaint database
Responsible for receiving, reviewing, and entering data into the Complaint Management Database regarding customer/patient product inquiries and complaints using good documentation practices (GDP)
Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action
Ensures that durable Equipment CRM Technical Service reports are correctly identified as to status for transfer into system
Determines product and incident complaint codes based on the master symptom code severity list
Notifies customer of receipt of product inquiry/complaint and provides preliminary support as required
Prepares other customer communication (response letters, acknowledgement letters) as appropriate
Partners with sales, marketing, and manufacturing departments to resolve product problems and provides feedback to customers as needed
Assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure
Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints
Interfaces with Corporate Quality Engineering and the RTG manufacturing sites as required for product investigations/trends
Adheres to the FMCNA Compliance Program, including following all regulatory and division/company policy requirements
Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business

Skills

Post Market Surveillance

Complaint Management

GDP

CRM

Data Entry

Trend Analysis

Quality Engineering

Customer Service

Product Investigation

Documentation

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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