REMOTE Medical Device Complaint Analyst

REMOTE Medical Device Complaint Analyst Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference. To learn more, visit our website: www.vyaire.com Watch our video: https://youtu.be/vE6nTH_FElA The Impact You’ll Make in this Role As a(n) Complaint Analyst, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Demonstrate working knowledge of product lines and how products are used and serviced by customers. Demonstrate experience in collecting basic information from customers and the knowledge gained from their specific customer experience. Follow written procedures and follow approved flow charts to determine the significance of each complaint received. Escalate complaints as defined by a system/process. Objectively and accurately document customer feedback without adding personal bias/opinion. Ask appropriate questions based on experience gained from other complaints and product knowledge. Forward information to appropriate internal parties as defined in written procedures, including complaint assessment based on formal flow charts, documentation and product knowledge. Write or review customer closure letter prior to closing complaint file. Assess complaint for determination of vigilance and/or adverse event reporting for US, Canada, and EU. Prepare and submit USFDA’s MedWatch 3500A report, Health Canada’s MDPR, and/or EU’sMDV report as needed. Assist colleagues in providing counsel to others on complex issues; aid in the development of strategies for achieving internal/external customer goals which consider cultural implications. Your Skills and Expertise To set you up for success in this role from day one, Vyaire is looking for candidates who must have the following qualifications: At least 2 years’ experience in Quality, Documentation Control, or Regulatory Affairs. Bachelor of Arts/Sciences Degree in Business or related field preferred Additional qualifications that could help you succeed even further in this role include: Working knowledge of Quality Assurance, Release and Configuration Management, and Regulatory Affairs. Customer facing experience. Computer and time management skills. Organizational and problem-solving skills. Must be self-motivated and able work with minimal guidance in own area of knowledge Travel: May include up to [10%][domestic/international] Relocation Assistance: May be authorized Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees. Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Atlanta, GA, Chicago, IL, Cincinnati, OH, Detroit, MI, Houston, TX, Miami, FL, Milwaukee, WI, Nashville, TN Full time We aspire to a “higher calling”, aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices. Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories. We are transforming the future of respiratory care; explore how you can be a part of it. We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day. One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic. To learn about our terms of use, please review Terms & Conditions. Also, provided here is a link to our Privacy Policy