APAC Manager, Quality and Regulatory

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Location: AP CHN Beijing - CFN Emp @ BD Site, CN
Job Category: Quality & Regulatory Affairs
Position Description
APAC Manager, Quality and Regulatory

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 International Manager, QRA. This position provides regional support will be provided for this position to the QRA Director for AsiaPac.  This role will report to the Regional Director, 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:

  • Acts as a point person for the region for regulatory agency interactions (either written or oral)
  • Acts as the point person for the region for post market quality activities.
  • Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.
  • Deploy, maintain, and execute a world-class medical device Regulatory Affairs system.
  • Develop and maintain relationships with regulatory peers, QA support, and other business and strategic partners.
  • Provide expertise and guidance in interpreting regional 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.
  • Provide input on sourcing and supply chain activities.
  • Provide expertise and leadership for personnel in region to ensure that international reporting requirements are met. Work with appropriate regional notified bodies, and Ministry of Health bodies in establishing and maintaining compliant vigilance programs.
  • Support the team in the management and resolution of customer complaints.

You will have the opportunity to:

  • Improve patient outcomes
  • Meaningfully impact the company‚Äôs 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.

Education:

  • 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.

Some logistics:

  • Based in International Location (Beijing China).
  • Travel required up to 10%, including international.

AP CHN Beijing - East Gate Plaza (CFN Emp@BD Site)

Full time
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