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Director of Regulatory Affairs and Quality

2 months ago

Cambridge, Massachusetts, United States Philips Full time
Job Summary

We are seeking a highly experienced and skilled Director of Regulatory Affairs and Quality to lead our Regulatory Affairs and Quality teams in the development and execution of compliant regulatory strategies and quality team/QMS responsibilities.

Key Responsibilities
  • Regulatory Affairs Strategy and Execution
    • Develop and execute end-to-end regulatory strategies for new product introductions and product changes, driving innovation and providing value-added regulatory affairs input and deliverables.
    • Use metrics and key performance indicators to drive regulatory and quality decision making, meaningful actions, and continuous improvement.
  • Regulatory and Quality Strategy and Execution
    • 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.
    • Develop and deploy regulatory and quality resources in an efficient and effective manner.
  • Team Leadership and Development
    • 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.
  • Stakeholder Engagement and Relationship Building
    • Build proactive, robust, strategic relationships with external stakeholders (FDA, Notified Bodies, Competent Authorities, MedTech forums, etc.) to influence and shape the external regulatory landscape across the domains relevant to the business unit innovation agenda.
  • Talent Management and Development
    • 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.
  • Quality Management System and Processes
    • 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.
  • Reporting and Communication
    • Reporting to the Business Leader, you will 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.
Requirements
  • Experience
    • A minimum of 10 years of experience working in Regulatory Affairs and Quality/Quality Operations within the FDA regulated Medical Device industry, including 3 years of experience and a strong track record in successfully leading/managing Regulatory Affairs and/or Quality teams.
  • Knowledge and Skills
    • 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 building/fostering strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities).
  • Education
    • A minimum of a Bachelor's Degree in Engineering, Life Sciences, Quality, Regulatory, or comparable disciplines.
  • Physical, Cognitive, and Environmental Job Requirements
    • The ability to successfully perform the minimum physical, cognitive, and environmental job requirements with or without accommodation for this position.
  • Work Authorization
    • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.