REMOTE Medical Device Senior Regulatory Affairs Specialist

REMOTE Medical Device Senior Regulatory Affairs Specialist 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 Regulatory Affairs Specialist I, 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: Representing Regulatory Affairs as a project core team member for product and manufacturing change projects. Assisting project teams in understanding applicable governmental regulations and agency guidelines. Reviewing proposed modifications to intended use, design, labeling, materials, and manufacturing processes to assess impacts on existing regulatory approvals/ clearances. Works with project teams to develop strategies and plans to handle the implementation of changes. Reviewing Engineering Changes and providing input outlining impacts to existing and in-process regulatory approvals/clearances. Preparing regulatory submissions to support product changes. Providing input to project teams on testing and documentation needed to support planned project submissions Reviewing labeling and proposed labeling changes for Regulatory compliance. Maintaining awareness of global regulatory legislation. Working in close collaboration and partnering with other departments and functions, including manufacturing, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness. Support external regulatory audits and inspections. 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's Degree. 3 years of Regulatory Affairs experience in a regulated industry. Additional qualifications that could help you succeed even further in this role include: Experience with international medical device regulations and submissions. Master of Science degree in engineering or a scientific/technical field. Certified Quality Manager or Regulatory Affairs Certification (RAC). Willing to learn and adapt to a changing environment. Strong technical writing skills. High-energy, results-oriented contributor with excellent collaboration and project management skills. Ability to fluently read, write, and speak in English is required. Detail oriented. 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. Base range in the Irvine, CA area for the Senior Regulatory Affairs Specialist position is $93,900 - $140,900. Additional benefits offered include medical, dental, vision, paid leaves, life insurance, 401k, paid time off, paid holidays and potential for tuition reimbursement. Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Atlanta, GA, Chicago, IL, Detroit, MI, Houston, TX, Irvine, CA, Milwaukee, WI, Minneapolis, MN, Nashville, TN, Orlando, FL 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. 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