Senior, Complaints Manager

React Health Holdings, LLC•Dublin, OH

3h•$98,000 - $155,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

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.

Responsibilities

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.