Sr. Post Market Surveillance Specialist

Fresenius Medical Care - Waltham, MA (30+ days ago)3.6

Receives, reviews, processes, and analyzes all product inquiries and product complaints for manufactured and distributed products (equipment, drug, and device) as required by applicable regulations, standards, and company policy. Helps provide high level customer support and serves as a liaison and subject matter expert between manufacturing facilities, distribution centers, customer/technical service, and customers/patients regarding product complaints. Partners with Pharmacovigilance resources on any possible adverse event (MDR/ADE) or reportable complaints, as well as with Corporate Quality Engineering on product investigations and trends. Responds to questions and liaises with fellow department staff members regarding complaint data entry and processing.

A seasoned, experienced professional with a full understanding of complaint handling/post market surveillance, resolves a wide range of issues in creative ways.
Ensures complaints are processed in a uniform and timely manner, whether they are equipment, drug, or device origin and those oral complaints are documented upon receipt using good documentation practices (GDP).
Responsible for receiving, reviewing entering, evaluating data into the Compliant Management Database regarding customer/patient product inquiries and complaints and further processing complaint files.
Interfaces with Customer Service and customers/patients to gather additional information required for complaint investigations, including the retrieval of product samples.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
Networks with senior internal and external personnel in own area of expertise.
Normally receives little instruction on day-to-day work, general instructions on new assignments.
Provides training during orientation and on-boarding of new staff. Mentors staff members regarding complaint processing. Acts as a resource for department staff members on complex complaints.
Applies knowledge of drug/device regulatory requirements in order to support Post Market Clinical Surveillance MDR/ADE reporting decision process within regulatory timeframes.
Processes MDR/ADE decision trees and is able to complete MDR submissions.
Understands the Field Alert Reporting (FAR) process and evaluate, distinguish, and recommend complaints for FAR reporting.
Understands complaint data analysis and is able to present complaint trends to management.
Provides coding support and reviews and updates complaints in the Compliant Management Database
Determines product and incident complaint codes and responds to questions regarding complaint coding from staff members.
Assigns complaint class based on the master symptom code severity list
Notifies customer of receipt of product inquiry/complaint and provides preliminary support as required. Refers complex inquiries to principal level staff and/or supervisor/manager, as needed.
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.
Responsible for maintaining complaint files within a secured environment.
Ensures complaint responses and any reply to the complainant is documented in the complaint file when applicable.
Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
Interfaces with Corporate Quality Engineering and manufacturing sites for product investigations and trend reporting.
Assists with department CAPA duties as assigned.
Responsible for MDR/ADE submission reportable malfunctions/serious injuries and post medical record review and system level MDR/ADE submissions. Acts as MDR/ADE pre submission reviewer.
Assists management with work flow specialist assignments.
Assists management with SOP revisions/annual document review.
Strives to meet Accuracy Goals (95% accuracy goal). Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
Ensures the timely closure of all complaint files in a consistent and timely manner and ensures that all pertinent information is contained within the file prior to closure and monitors and reports on complaint closure as required.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
Assists with various projects as assigned by a direct supervisor.
Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Bachelor’s Degree required, preferably in a healthcare related field.

Minimum 5 – 8 years of related experience in complaint handling in the healthcare/device industry with exposure to medical device quality system regulations, and an understanding of drug/device safety requirements; with an Advanced Degree a minimum 3 years of experience is acceptable.
Requires understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820.198 and 21 CFR 211).
Strong interpersonal and decision making skills.
Strong PC computer skills essential in industry recognized complaint management systems, crystal reporting, MS Access/Excel.
Understanding of medical terminology.
Experience in FDA regulated environment, pertinent to ISO 13485 is preferred.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity