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Regulatory Affairs Manager

Company Name: Vyaire Medical
Location: Irvine, 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:

Vyaire Medical is a unified breathing company that focuses on improving the lives of those treated with our devices.  We are a recognized leader in the Respiratory Diagnostics, Ventilation, and Anesthesia Delivery, and Patient Monitoring market segments.  Vyaire Medical is also the largest pure-play company of its kind.

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.
  • 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 products.
  • Evaluates manufacturing changes for regulatory impact and to ensure compliance with applicable regulations.
  • Provide expertise in interpreting US and foreign governmental regulations, agency guidelines, and corporate policies to ensure compliance and results are achieved.
  • Participate in Management Review process, including the identification, generation, and reporting key performance indicators for monitoring patient, product, & business risk. 

Job Requirements:

Experience needed:

  • 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.
  • 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.

 Education:

  • Bachelor of Science degree in engineering or a scientific/technical discipline.
  • Master of Science degree in engineering or a scientific/technical discipline preferred.
  • Six Sigma Black Belt or Master Black Belt desired.
  • Certified Quality Manager or Regulatory Affairs Certification (RAC) preferred.

 Location 

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