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Vyaire Medical Regulatory Affairs Advisor in Indianapolis, Indiana

Regulatory Affairs Advisor

About US

At Vyaire, we help the world breathe easier. 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://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be

About this role

Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.

As a Regulatory Affairs Advisor, you will report to the Manager of Regulatory Affairs for Vyaire and have a hands-on role in regulatory submissions which will directly impact our customers and the business.

  • Develops regulatory strategies for lifecycle management projects and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by regulatory authorities

  • Manages the preparation of registration packages and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and internal technical teams. Author with team members, key pieces of regulatory submissions.

  • Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products/teams

  • Review labeling for Regulatory compliance.

  • Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations.

  • Maintains awareness of global regulatory legislation and its impact on business and product development programs.

  • Provide expertise and guidance to project teams in interpreting US and foreign governmental regulations, agency guidelines, and internal/corporate policies to ensure compliance is maintained and results are achieved.

  • Work in close collaboration and partner with other departments and functions, including manufacturing, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness while developing and maintaining a best-in-class Regulator Affairs program.

  • Support external regulatory audits and inspections.

  • Provide regulatory input on sourcing and supply chain activities.

  • Support Regulatory compliance activities

  • Improve patient outcomes

  • Meaningfully impact the company’s short-term and long-term success

  • Work closely with executives across the organization

  • Grow your role as you see fit

  • Learn about respiratory medical device manufacturing

  • Create an inspiring and productive workplace

Qualifications:

  • This position requires 3+ years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with direct experience in Regulatory Affairs.

  • Be a high energy, results-oriented contributor with excellent collaboration and project management skills

  • Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements (e.g. FDA QSR and ISO/EN standards)

  • Demonstrated ability to work constructively across all functions of the organization

  • Willingness to do what it takes

  • Bachelor of Science degree in engineering or a scientific/technical discipline.

  • Master of Science degree in engineering or a scientific/technical discipline preferred.

  • Master of Business Administration degree preferred

  • Six Sigma Black Belt or Master Black Belt desired.

  • Certified Quality Manager or Regulatory Affairs Certification (RAC) preferred.

  • Ability to fluently read, write, and speak in English is required.

  • Based in Mettawa, Illinois, Yorba Linda, California, or International

  • Travel required up to 10%, including international.

Atlanta, GA, Boston, MA, Cleveland, OH, Dallas, TX, Hartford, CT, Indianapolis, IN, Irvine, CA, Los Angeles, CA, Madison, WI, Mettawa, IL, Milwaukee, WI, Minneapolis, MN, New Haven, CT, Philadelphia, PA, Phoenix, AZ

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.

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