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Regulatory Manager

Company Name: Vyaire Medical
Location: Yorba Linda, CA
Job Type: Full Time
Contact Name: Sara Orzech
Phone: 248-764-4047
Fax:
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Salary: Competitive

Job Description

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 who will 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.
  • Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
  • 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
  • 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.


Job Requirements 

Experience needed: 

  • A minimum of 8 years related experience in the medical device, pharmaceutical, and/or medical diagnostics industry, with at least 4 years of increasing responsibility in Regulatory Affairs, both domestic and international.
  • Proven ability to prepare, analyze and submit documents to FDA, such as 510(k) Premarket Notifications, Investigational Device Exemptions (IDEs), or Premarket Approval Applications, (PMAs).
  • Excellent understanding of FDA, International ISO and IEC Standards, Medical Device
  • Directives (93/42/EEC), Canadian Medical Device Regulations and other International Regulation regulatory requirements.
  • Knowledge of regulated Quality Systems, Corporate, Regulatory and Global (FDA, ISO, JPAL, etc.) Guidelines pertinent to product/package labeling.
  • 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)
  • International work experience.
  • This position requires a four year Bachelor’s degree; preferably in Engineering, Physical Science,
  • Master of Science degree in engineering or a scientific/technical discipline preferred.
  • Six Sigma Black Belt or Master Black Belt strongly, RAPS Certification, ASQ Certified Quality Manager desired.
  • Experience developing and leading risk monitoring programs. 

Location 

  • Will be based in Yorba Linda, California.
  • Travel required up to 30%, including international.