Global Compliance Manager

1 week ago


Santa Rosa, California, United States Medtronic Full time

Senior Manager, Regulatory Affairs - Structural Heart & Aortic (hybrid)

About the Role

We are seeking a seasoned Regulatory Affairs Professional to lead global regulatory strategies for transcatheter valve technologies at Medtronic. This role involves overseeing a team, collaborating with stakeholders, and ensuring compliance with regulatory requirements.

Key Responsibilities

  • Develop and Implement Regulatory Strategies for transcatheter valve products, ensuring alignment with company goals and objectives.
  • Lead a Team in regulatory approvals and submissions, providing guidance and support to ensure successful outcomes.
  • Collaborate with Regulatory Authorities and stakeholders to ensure compliance with regulatory requirements and industry standards.
  • Provide Guidance on regulatory requirements and compliance, ensuring that all team members are aware of and adhere to regulatory standards.
  • Manage Regulatory Review of materials and product claims, ensuring that all regulatory requirements are met.

Requirements

  • Bachelor's Degree with 7+ years of regulatory affairs experience, 5+ years of managerial experience.
  • Advanced Degree with 5+ years of regulatory affairs experience, 5+ years of managerial experience.

Preferred Qualifications

  • 10+ Years of Medical Device regulatory affairs experience.
  • Advanced Degree in Regulatory Affairs or a technical field.
  • Strategic Thinking and problem-solving abilities.
  • Experience with global submissions.


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