Senior, Complaints Manager

POSITION: Senior, Complaints Manager

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 Senior Complaints Manager will focus on managing the complaint handling process, and lead and manage the complaint handling team. This individual will participate in and coordinate investigations, file MDR's, update files, provide customer responses and ensure the complaint process functions in accordance with Quality Management procedures.

QUALIFICATIONS
Key qualifications and experience include:

• At least 9 years of experience required in complaint handling and medical devices
• Bachelor's degree in engineering, life sciences or related field
• Familiarity with electronic quality management systems, e.g. TrackWise
• Experience and understanding of the overall business environment and required regulations including FDA 21 CFR 803/806/820, ISO 13485:2016
• Understands Risk Management files and how they relate to complaints.
• Comprehensive understanding of Medical Device Reporting to the FDA
• Comprehensive understanding of evaluating service events for assessment of complaints
• Experience in reporting MDRs to the FDA, and adverse events in other geographies
• Ability to build relationships throughout the business and work with cross functional teams
• Demonstrated ability to manage multiple competing priorities and facilitate projects
• Ability to extrapolate and report data using statistical techniques and make data driven decisions

Preferred Education

• Masters degree in life sciences or engineering disciplines

Preferred Experience

• Excellent attention to detail and project management skills.
• Excellent written/oral communication skills required. Must be able to work effectively with 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, 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.
• Travel 10%

DUTIES AND ESSENTIAL FUNCTIONS

• Each Employee consistently demonstrates the following essential functions:
• Support product lines in markets within and outside US.
• Develop, implement, and maintain and improve Complaint and MDR procedures including interface with service department and complaint investigation unit, and Engineering teams
• Participate in the complaint handling process as required
• Works 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
• Responsible to create and submit MDRs and Adverse Events to regulatory agencies within required timeframes
• Maintain the complaint database
• Provide complaint trending and reporting for quality data reviews and Management Reviews
• Identify and lead process improvements
• Participate in software validation of complaint handling systems
• Participate in internal and external audits and inspections
• Participate in training development and implementation for company personnel required to learn about complaint handling
• Attends and participates in departmental meetings.
• Attend seminars and training sessions necessary to maintain appropriate level of professional competence.
• Ensures all department compliance guidelines are met.
• Attend 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.

Pay Range: $98,000 - $155,000 per year