at Vyaire Medical in Chicago, Illinois, United States
Job Description
Remote Senior Complaint Regulatory Reporting Analyst – Complainant Management
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 Senior Complaint Regulatory Reporting Analyst – Complainant Management, 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:
+ Assessing complaints for reportability determination of vigilance and/or adverse event reporting globally.
+ Reviewing applicable Risk Management Files against complaints to ensure all failure modes are captured appropriately.
+ Preparing and submitting global regulatory reports worldwide for example: USFDA’s MedWatch 3500A report, Health Canada’s MDPR, and/or EU.
+ Demonstrating experience in collecting any required information to properly determine reportability from customers and the knowledge gained from their specific customer experience.
+ Following written company procedures and following approved flow charts to figure out significance of each complaint received.
+ Advancing complaints as defined by the Vyaire system/process and applicable regulatory reporting requirements.
+ Objectively and accurately detailing customer feedback without adding personal bias/opinion.
+ Asking appropriate questions based on experience gained from other complaints and product knowledge.
+ Forwarding information to appropriate internal parties as defined in written procedures, including complaint assessment based on formal flow charts, documentation, and product knowledge.
+ Writing or reviewing customer closure letters prior to closing complaint file.
+ Identifying product issues and advancing as needed for CAPA, Field Action, and Supplier Corrective Action as required and according to Vyaire procedures.
+ Performing routine analysis, following the correct steps and using the appropriate tools, including observing and seeking guidance from senior staff when necessary.
+ Partnering with relevant parties to deliver solutions.
+ Responding directly to internal/external customers regarding routine requests in a timely manner.
+ Assisting 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.
+ Assisting in implementing the change process and measuring results by providing data and analysis.
+ Demonstrating a can-do attitude to meet short- and long-term objectives
Your Skills and Expertise
To set you up for success in this role from day one, Vyaire is looking for candidates who have the following required qualifications:
+ Bachelor of Science Degree. Prefer BS in Respiratory, Nursing, or another clinical degree.
+ 4+ years of experience in Quality, Documentation Control, Regulatory Affairs, or Clinical.
Additional qualifications that could help you succeed even further in this role include:
+ RN or RRT.
+ Experience and knowledge in global vigilance reporting requirements particularly for the 5 MDSAP countries; Australia, Brazil, Canada, Japan and the United States.
+ Demonstrate in-depth knowledge of MDD and EU MDR regulations medical device vigilance reporting.
+ Working knowledge of Quality Assurance, Release and Configuration Management, and Regulatory Affairs.
+ Customer facing experience.
+ Experience of electronic complaint management systems
+ Organizational and problem-solving skills.
+ Solid understanding of Microsoft Office particularly Excel.
Travel: May include up to [10%][Domestic]
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).
Chicago, IL, Dallas, TX, Irvine, CA, Los Angeles, CA, Mettawa- HQ, Phoenix, AZ, San Diego, CA, Washington – FIELD Seattle Met
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 (http://www.vyaire.com/terms-of-use) . Also, provided here is a link to our Privacy Policy (http://www.vyaire.com/privacy-policy)
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.
