Manager, Regulatory Affairs
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 Affairs Manager. This role will report to the Director of Regulatory Affairs for Vyaire, and have a hands-on role in defining, deploying, and leading regulatory strategies that will directly impact our customers and the business.
In particular, you can expect to:
- 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.
- Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations.
- Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
- Execute people management responsibilities, provide managerial support and training to employees by supervising staff, establishing employee goals that align with other business partners, maintaining job descriptions, creating employee development plans, providing performance feedback and recruiting and retaining staff members.
- Deploy, maintain, and execute a world-class medical device Regulatory Affairs system.
- Oversee generation, revision, and review of Regulatory Affairs documents consistent with the evolving interpretations of current regulatory submission standards and guidance.
- Develop and maintain relationships with regulatory peers, QA support and other business and strategic partners.
- Perform and support due diligence activities in support of Vyaire business strategy deployment.
- Provide expertise and guidance 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.
- Mentor and coach the critical thinking, regulatory pathway problem solving, and technical writing skills of product and process engineering teams in support of regulatory submissions.
- Participate in the administration and execution of external regulatory audits and inspections and serve as the Regulatory Affairs subject matter expert.
- Provide input on sourcing and supply chain activities.
- Actively participate in the Management Review process, including the identification, generation, and reporting of key performance indicators for monitoring patient, product, and business risk.
- Participate with peers in the formulation of overall direction, processes, systems, and talent development for the Regulatory Affairs organization.
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:
- A minimum of 7 years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 5 years of experience in Regulatory Affairs.
- Be a high energy, results-oriented leader with excellent collaboration and project management skills.
- Demonstrated product design, manufacturing, and supply chain process expertise.
- 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, including direct auditing activities at times.
- International work experience.
- 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 Yorba Linda/Irvine, California or Mettawa, IL.
- Travel required up to 30%, including international.