Medical Device Complaint Handling Specialist
Fort Worth Metro Area, TX
Responsible for day-to-day case management of quality technical and adverse event complaint
records, including intake, follow up, triage and system entry, involving device
products. Complaint handling accountabilities reflect activities required to comply with
local and international regulations, guidelines, and applicable directives.
Receive initial complaint from any source (ECPs, patients, internal personnel)
and assure all information/data is accurately captured at point of contact.
Maintain an understanding of information/data required to be collected for technical
and AE complaints to assure compliance with regulations and directives.
Manage technical and adverse event complaint records for assigned area(s) using
designated safety system(s)
o Review potential complaint data received via safety system(s) and other methods,
o Is cognizant of, and works efficiently within applicable timezones
o Performs intake / follow up / data entry activities and attaches corresponding
source documents in a timely manner per requirements and directives.
o Performs data entry for affiliates without access to safety database(s).
o Triage call from all sources for quality technical complaint, Adverse Event,
request for refund, request for replacement product and request for credit.
o Reviews data entry and follow-up activities for completeness and timeliness
o Closes files according to established guidelines to meet required timelines
Maintains a working knowledge of:
o company policies and procedures, departmental processes, and associated work
o evolving local and international regulations, guidelines and applicable directiv
o products for assigned therapeutic area(s) and corresponding documentation
(Product Inserts, DFUs, Manuals, Promotional Materials)
o eye anatomy, common diseases, ophthalmic procedures
o eye terminology and abbreviations
o safety databases(s) and reporting tools
Informs management of potential safety issues, emerging trends and/or concerns
3-5 years clinical experience in a medical device setting ophthalmology and O.R preferred
1-3 years relevant work experience (i.e. Device/Drug Safety/ Complaint Handling/ Customer Service/ Communications)
Excellent time management and prioritization skills
Ability to work effectively within strict timelines
Task and detail-oriented
Ability to work in a global cultural environment
Computer proficiency (data entry, retrieval and analy-sis)
Excellent written and verbal communication skills
Sensitive to confidentiality of data
Strong interpersonal, communication, and problem solving skills
Self-starter/ Ability to work under pressure with tight timelines
Culturally aware/ Experienced working with cross functional teams