Regulatory Affairs Director

3 days ago


Reston, Virginia, United States LDI Group Full time

Senior Director Regulatory Affairs

Job Summary

We are seeking a seasoned Senior Director Regulatory Affairs to lead our global regulatory function and drive strategic growth. As a key member of our leadership team, you will be responsible for developing and implementing a best-in-class regulatory program, aligning with our company's worldwide aspirations.

Key Responsibilities

  • Develop and execute a global regulatory strategy, ensuring compliance with regulatory requirements and industry standards.
  • Lead the planning and execution of regulatory submissions, including 510K, De Novo, and 513 Regs.
  • Partner with business leaders to provide regulatory guidance and support the development of innovative products.
  • Build and maintain relationships with regulatory bodies, including the FDA.
  • Develop and implement a regulatory culture and mindset within the organization.
  • Establish and maintain a regulatory framework that supports business growth and compliance.

Requirements

  • Proven leadership experience in a senior Regulatory Affairs role, with a track record of driving strategic growth.
  • Experience with Medical Device, diagnostics, IVDs, Software products, or similar products.
  • Submissions experience (Global) – 510K, De Novo, 513 Regs.
  • Prior history partnering with business leaders to provide regulatory guidance.
  • Experience forming and implementing global regulatory strategies/programs.

About LDI Group

LDI Group is a global leader in innovative product development and advancement. We are committed to making the world a healthier place and are seeking a talented individual to join our team.



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