Regulatory Affairs Specialist
As Vyaire strives for continued improvement and future growth, it is continuously seeking top talent who are inspired by our purpose to bring therapies to patients that significantly improve their lives. Vyaire seeks an experienced, passionate, and dynamic Regulatory Individual. This role 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.
In particular, you can expect to:
- Prepares regulatory submission for submission, including US 510K, European Union Technical File, and Health Canada submissions. Provide business level support for International Registrations.
- Review labeling for Regulatory compliance.
- 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.
- Support external regulatory audits and inspections.
- Provide regulatory input on sourcing and supply chain activities.
- Support Regulatory compliance activities.
You will have the opportunity to:
- 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
To be successful, you will need:
- Title and responsibilities will be linked to experience. This position requires 1-3 years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with a preference for 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.
- 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 or Irvine, California.
- Travel required up to 10%, including international.
Irvine, CA, Mettawa- HQ