Complaint Specialist II (Remote)

POSITION: Complaint Specialist II

FULL-TIME/PART-TIME: Full Time

LOCATION: Dublin, OH

React Health is a fast-paced, growth-driven manufacturer and distributor of medical equipment, dedicated to supporting patients, caregivers, physicians, and healthcare providers. With a focus on respiratory and sleep health sectors, we offer a comprehensive range of products and services across acute care, non-acute care, and home medical equipment. By integrating manufacturing and distribution, React Health addresses the needs of both undiagnosed individuals and those requiring therapy after diagnosis, particularly within the sleep and respiratory care sectors.

GENERAL SUMMARY

The Complaint Specialist II will focus on the complaint handling process. This individual will input and evaluate customer complaints in the ReactHealth complaint management system. This individual will also participate in and coordinate investigations, update records, provide customer responses and ensure timely closure of complaints in accordance with FDA (US) and Competent Authority (EU) Regulations.

QUALIFICATIONS

The position requires at least 3 years of experience in medical device complaint handling and/or medical device compliance, preferably both.

Experience with/ or understanding of, the overall business environment, quality management systems and related regulations including: FDA 21 CFR 803; FDA 21 CFR 806; FDA 21 CFR 820,198;ISO 13485:2016

Familiarity with electronic quality management systems.

Ability to build relationships throughout the business and work with cross functional teams.

Demonstrated ability to manage multiple competing priorities and facilitate projects.

Preferred Education

A minimum of a bachelor’s degree in engineering, life sciences or related field.

Preferred Experience

Experience with personal computers and Microsoft Windows® based Operating Systems

Experience with TrackWise or other QMS software.

Proficient in the use of Microsoft Office® Applications including MS Word®, MS Excel®, MS PowerPoint®, MS Outlook®, MS Teams®

Exposure to FDA Medical Device Reporting (MDR) via Form FDA 3500A with submitter and through the FDA ESG Gateway

Familiarity with Device Risk Management principles and documents including Failure Mode Effects Analysis (FEMA) and Hazard Analysis.

Excellent attention to detail and project management skills.

Excellent written/oral communication skills required. Must be able to work effectively within diverse groups of people.

Physical Demands

Requires normal visual acuity and hearing.

Typically, employees sit comfortably to do their work, interspersed by brief periods of standing, walking, reading, bending, carrying papers and books, and extensive periods requiring the use of computer terminals to accomplish work objectives.

Required to sit and use their hands and fingers to handle or feel and manipulate keys on a keyboard.

Additional skills may be required to perform additional task(s) specific to work location, department or line of business.

Working Conditions

Predominantly operates in an office environment. Some work (less than 5%) requires moving and lifting of heavy networking equipment.

DUTIES AND ESSENTIAL FUNCTIONS

Each Employee consistently demonstrates the following essential functions:

Receive/document complaints and complete complaint evaluation.

Follow up with initial complaint reporters to obtain additional complaint information as required.

Perform, /coordinate, and document complaint investigations.

Work cross functionally to ensure timely complaint closure.

Determine Medical Device Reporting in accordance with 21 CFR Part 803 Medical Device Reporting and 806 Corrections and Removals and other international regulatory reporting (ISO 13485:2016 8.2.2 Complaint Handling and 8.2.3 Reporting to Regulatory Authorities).

Create and submit MDRs to regulatory agencies within required timeframes.

Identify and lead process improvements.

Attends and participates in departmental meetings.

Attends seminars and training sessions necessary to maintain appropriate level of professional competence.

Ensures all department compliance guidelines are met.

Attends all meetings., in-services training, or continuing education as delegated by the supervisor.

Provides customer focused interactions.

Performs all duties necessary for the department as per department policies and procedures.

Performs other duties and responsibilities as delegated by the supervisor within the scope of practice and the responsibilities in the department.

Reasonable accommodations may be made to accommodate individuals with disabilities to perform the basic functions of the position without compromising client care. React Health is an Equal Opportunity/Affirmative Action Employer and is committed to providing a drug-free workplace. We are an Equal-Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or local protected class.