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Quality Manager, Labeling Jobs

Company

Vyaire
Address , Irvine, Ca
Employment type FULL_TIME
Salary
Expires 2023-07-21
Posted at 1 year ago
Job Description
Quality Manager, Labeling
Help the World Breathe Easier by Collaborating with Innovative Vyaire Employees Around the World
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://youtu.be/vE6nTH_FElA
The Impact You’ll Make in this Role

As a(n) Quality Manager, Labeling, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:
  • CAPA ownership and progression as required.
  • Demonstrating a broad knowledge of product development process
  • Guiding development, deployment and maintenance of labeling documentation, procedures, and supporting systems
  • Providing leadership regarding the development and implementation of labeling in regards to the regulatory strategy and documentation for marketed products and products in development
  • Providing guidance, as required, on requirements
  • Perform other duties as assigned.
  • Managing and supporting of the labeling team that creates product labelling and maintains the labeling portfolio; interfacing with the engineering, operations, marketing, quality and regulatory functions
  • Providing leadership and direction to the Labeling team
  • Staying current with external and internal labeling standards and requirements and provide guidance to the organization regarding the potential impacts; Communicating changes in regulations and practices to the organization effectively and in a timely manner, then ensure implementation strategies are developed for business units
  • Accountable for escalating labeling resource constraints
  • Leading the team to ensure alignment of overall key labeling statements, key messages, and formats across portfolio of products
Your Skills and Expertise
To set you up for success in this role from day one, Vyaire is looking for candidates who must have the following qualifications:
  • Minimum five (5) years in a quality or regulatory affairs role within a medical device, pharmaceutical, and/or medical diagnostics company
  • Bachelor's degree or foreign academic equivalent
Additional qualifications that could help you succeed even further in this role include:
  • Possess sound judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements
  • Strong technical acumen, excellent verbal and written communication skills, strong multitask and situational management, personal and team leadership skills, strong interpersonal skills, excellent computer skills, results oriented, able to resolve complex customer related issues
  • Knowledge of global medical device labeling regulations and standards (i.e. FDA, ISO 1485, EU MDR, etc.)
  • Supervisory or manager experience
  • Must be capable of interfacing with executive level of management and health care professionals
Travel: May include up to [10%][domestic]
Relocation Assistance: May be authorized
Benefit elections are among the most meaningful choices that we make for ourselves and our family. That is why Vyaire offers a comprehensive benefits package that includes various options to meet the diverse needs of our employees.
Base range in the Irvine, CA area for the Quality Manager, Labeling position is $115,000 - $172,500. Additional benefits offered include medical, dental, vision, paid leaves, life insurance, 401k, paid time off, paid holidays and potential for tuition reimbursement.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). (Must approve with your HRBP if you wish to remove this)
Irvine, CA
Full time