Regulatory Affairs Director

1 week ago

Orange, California, United States Philips Full time

Job Summary:

The Director of Regulatory Affairs will lead the Philips RespirTech InCourage Vest Therapy Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.

Your Role:

  • Develop and execute regulatory and quality strategies to maintain current products and bring new products to the market in an efficient manner.
  • Lead the development and execution of regulatory and quality strategies to maintain current products and bring new products to the market in an efficient manner.
  • Proactively build regulatory and quality capabilities within the business.
  • Provide practical interpretation/guidance of regulations, standards and input including risk assessment to support business decision making.
  • Build proactive, robust, strategic relationships with external stakeholders (FDA, NBs, CAs, MedTech forums etc.) to influence and shape the external regulatory landscape across the domains relevant to the business unit innovation agenda.
  • Manage, oversee, hire and develop talent within the Regulatory Affairs and Quality teams through creating and sustaining robust career & development plans, ongoing coaching and feedback, and identifying and addressing gaps in capabilities and competencies.
  • Ensure compliance with regulatory requirements and internal procedures.
  • Empower and enable regulatory affairs and quality team members to foster a culture of collaboration and confident decision-making when working in cross-functional programs and projects.
  • Manage/oversee execution of inspection readiness activities, including active inspection support.
  • Participate in the coordination and execution of the internal audit program.
  • Manage/oversee recall efforts, compliant handling, failure investigation, and adverse event reporting.
  • Management, maintenance, and evaluation of the Quality Management System and processes for optimization and continuous improvement.
  • Track and prepare GXP internal and external metric reports periodically, including annual review with the Leadership team.
  • Lead and enable strong cross-functional partnerships with key stakeholders including R&D, Marketing, Quality, Clinical Affairs and other functions at all levels within the Business Unit.
  • This role may require travel up to 10%.
  • Company relocation benefits will be provided for this position.

Requirements:

  • A minimum of 10 years' experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, including 3 years' experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams.
  • Extensive experience/knowledge of global medical device regulations, requirements, and standards (ISO 13485, ISO 14971, 21 CFR 820, etc.)
  • A proven track record leading cross-functional/diverse teams in a matrix organization, with challenging goals, with experience working in smaller companies desired.
  • Experience in building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
  • A minimum of a Bachelor's Degree (Required) in Engineering, Life Sciences, Quality, Regulatory or comparable disciplines.
  • US work authorization is a precondition of employment.

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