Medical Device Complaints System Owner

1 week ago


Miami, Florida, United States Katalyst HealthCares & Life Sciences Full time
Complaints Manager Role

Katalyst HealthCares & Life Sciences is seeking a skilled Complaints Manager to oversee the entire complaints system for Class II medical devices.

About the Role

We are looking for an experienced professional to handle the post-market quality team's complaints, focusing on reporting and handling incidents. The ideal candidate should have experience with managing complaints systems, writing reports, and owning incident management processes.

Duties and Responsibilities
  • Manage the entire complaints system for Class II medical devices, ensuring compliance with regulations.
  • Handle and report all complaints, focusing on providing timely and effective resolutions.
  • Owning the process of writing HHE's (Health Hazard Evaluations) and MDR's (Medical Device Reports), in collaboration with relevant teams.
Requirements and Qualifications
  • At least + years' experience in managing complaints systems, preferably in both large and small companies.
  • Familiarity with electronic complaint handling tools, such as JIRA (Plus).
  • Experience with CAPA (Corrective Action and Preventive Action) processes is a significant advantage but not essential.
About Katalyst HealthCares & Life Sciences

We offer a dynamic work environment that encourages growth and development. Our company is committed to delivering high-quality services to our clients.

The estimated salary for this role is $85,000 - $110,000 per year, depending on experience.


  • Complaints Manager

    4 weeks ago


    Miami, Florida, United States Katalyst HealthCares & Life Sciences Full time

    Job Description: We are seeking a highly experienced Complaints Manager to join our team at Katalyst HealthCares & Life Sciences. The ideal candidate will have a strong background in managing complaints systems, particularly for Class II medical devices. This role is a great opportunity for someone who enjoys working in a fast-paced environment and is...


  • Miami, Florida, United States North Shore Medical Center Full time

    Job SummaryWe are seeking an experienced Electrical Systems Specialist to join our team at North Shore Medical Center. This is a unique opportunity to work in a fast-paced hospital environment, maintaining and installing electrical circuits, devices, and controllers.As an Electrical Systems Specialist, you will be responsible for maintaining all emergency...


  • Miami, Florida, United States ExtendMyTeam Full time

    Job Title: Global Regulatory SpecialistWe are seeking a skilled professional to join our Quality and Regulatory team as a Global Regulatory Specialist. The successful candidate will be responsible for ensuring compliance with regulations in the CPG and medical device industries globally.


  • Miami, Florida, United States Frida Full time

    We are seeking a highly skilled Global Regulatory Specialist to join our Quality and Regulatory team at Frida, a leading manufacturer of medical devices and consumer goods. This role will be responsible for ensuring compliance with regulations across various regions, including the US, Canada, Mexico, EU, UK, Switzerland, and Saudi Arabia.As a Global...


  • Miami, Florida, United States Ferrer Pulmonary Institute Full time

    Ferrer Pulmonary Institute seeks a detail-oriented Regulatory Affairs Specialist to ensure compliance with regulations and standards in the development, manufacturing, and marketing of medical devices and medications.Key Responsibilities:Develop and implement compliance strategies to ensure adherence to regulatory requirementsPrepare and submit regulatory...


  • Miami, Florida, United States Strategic Systems Full time

    Job Summary">This position involves deploying and installing Dell PCs and VDI devices, ensuring cable management and area cleanup. The ideal candidate will have a strong understanding of technical systems and excellent problem-solving skills.">About the Role">We are seeking a highly skilled Systems Deployment Specialist to join our team at Strategic Systems...


  • Miami, Florida, United States TEKsystems Full time

    We are seeking an experienced Security System Service Technician to join TEKsystems in South Florida. This lucrative opportunity offers a competitive salary and benefits package.Job DescriptionThis role involves servicing, programming, and troubleshooting security systems and related devices in commercial and industrial settings.Servicing, troubleshooting,...


  • Miami, Florida, United States Jackson Health System Full time

    About the RoleWe are seeking a skilled Clinical Nurse Specialist to join our Medical Surgical Tele team at Jackson Health System. In this critical role, you will be responsible for delivering high-quality patient care and providing leadership in nursing practice.Job DescriptionThe Clinical Staff Nurse functions as a champion of quality patient care and...


  • Miami, Florida, United States TEKsystems Full time

    We are seeking a skilled Security Systems Specialist to provide commercial services for our clients. As part of the team, you will be responsible for servicing, programming, and troubleshooting security systems and related devices throughout South Florida.Job OverviewThis is a lucrative opportunity with a leading company in the commercial security alarm...


  • Miami, Florida, United States Raytheon Full time

    About RaytheonRaytheon is a leading technology company that solves complex challenges in aerospace and defense. Our mission is to provide innovative solutions that make a difference in the world.Job SummaryWe are seeking an experienced Embedded Systems Engineer to join our team in Tucson, AZ. The successful candidate will lead the development of FPGA designs...


  • Miami, Florida, United States TEKsystems Full time

    About the RoleWe are seeking experienced Alarm Technicians to complete service and installations on various different alarm panels and camera systems in residential settings. This job will be based in a lucrative opportunity to grow their skill set in the security industry and work with advanced security systems. The desired candidate will have previous...


  • Miami, Florida, United States Orion Electric Inc Full time

    Job OverviewOrion Electric Inc. is a leading provider of commercial and industrial electrical services in South Florida.We are seeking a highly skilled Electrical System Specialist to join our team. This role will be responsible for installing, maintaining, and repairing complex electrical control, wiring, and lighting systems.Key ResponsibilitiesInstall and...


  • Miami, Florida, United States SAIC Full time

    SAIC Cyber Team Lead - Systems AdministrationSAIC is seeking an experienced individual to join our team in support of the U.S. Southern Command's Cyber IT Enterprise Services (SCITES) project.The selected candidate will lead a team responsible for systems administration of platforms installed throughout the USSOUTHCOM Area of Responsibility (AOR). Key...


  • Miami, Florida, United States Crew Life at Sea Full time

    Job Summary:We are seeking a highly skilled Live Entertainment Systems Technician to join our team at Crew Life at Sea. This is a challenging and rewarding role that requires a strong background in audio, lighting, and video systems.Key Responsibilities:Conduct daily inspections of secondary venues to ensure equipment functionality and awarenessReport any...


  • Miami, Florida, United States SCRIVAS, LLC Full time

    We are seeking a detail-oriented and organized Medical Data Entry Specialist to join our team at Scrivas, LLC in Miami, Florida.As a Medical Data Entry Specialist, you will have the opportunity to work in a fast-paced environment and gain valuable experience in the medical field. You will be responsible for recording patient information, including chief...


  • Miami, Florida, United States North Shore Medical Center Full time

    Job OverviewWe are North Shore Medical Center, a leading healthcare provider offering continuous nursing, medical, and social services on a 24-hour basis. Our primary focus is on delivering exceptional patient care while fostering the professional growth of our staff.Our commitment to excellence extends beyond our patients to the communities we serve. We...


  • Miami, Florida, United States Jackson Health System Full time

    We are seeking a skilled Emergency Nurse Specialist to join our team at Jackson Health System, one of the largest public hospitals in the nation. This is an exciting opportunity for a dedicated and compassionate nurse to make a difference in the lives of patients and their families.Job SummaryThe Clinical Staff Nurse will function as a champion of quality...


  • Miami, Florida, United States Pure Freight Lines, LTD. Full time

    About the RolePure Freight Lines, LTD. is seeking a reliable and experienced Class A Owner Operator to join our team as a safety-conscious truck driver.Salary and BenefitsThe estimated annual salary for this role is $120,000-$150,000, depending on experience and performance. Our benefits package includes:An 80/20 split of revenueFREE trailer rental for...


  • Miami, Florida, United States Mount Sinai Medical Center Full time

    Job Opportunity:We are seeking a highly skilled Licensed Practical Nurse (LPN) to join our team at Mount Sinai Medical Center in Hialeah. As a LPN, you will play a vital role in delivering exceptional patient care and contributing to our legacy of high-quality healthcare.About Us:Mt. Sinai Medical Center has remained committed to providing access to its...


  • Miami, Florida, United States K-Laserusa Full time

    Job OverviewK-Laserusa is the leading manufacturer of Class IV laser therapy devices, with over 6000 installations in the USA. We are seeking a highly skilled Medical Laser Repair Specialist to join our team.This role requires a strong background in biomedical equipment repair technology and electrical instrumentation. The ideal candidate will have excellent...