Global Regulatory Affairs Lead, Medical Devices

Medtronic; Lafayette, Mounds View (CO, MN); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Medtronic in Lafayette, CO or Mounds View, MN seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies for the RST consumable portfolio. You will drive early development and lifecycle activities, align with cross-functional teams, and guide submissions for U.S.

and EU markets. You will collaborate with R&D, marketing, clinical, and operations to integrate regulatory considerations into product decisions and ensure compliant promotional practices.

Formación

• Bachelor's degree required.
• 7+ years of relevant regulatory affairs experience, or 5+ years with an advanced degree.
• Extensive experience in medical device regulatory affairs.
• Experience with U.S. Class II and III devices and EU MDR/ISO requirements.

Responsabilidades

• Lead and shape global regulatory strategies across the product lifecycle.
• Provide regulatory input for development pathways, classifications, and data needs.
• Serve as strategic partner to R&D, marketing, operations, and leadership.
• Oversee regulatory submissions for U.S. and EU markets.
• Review advertising and promotional materials for compliance and risk.
• Mentor junior regulatory staff and manage cross-functional collaboration.

Conocimientos

Regulatory leadership

Cross-functional collaboration

Regulatory strategy development

Regulatory submissions

Mentoring others

Educación

Bachelor's degree

Advanced degree (MS/PhD)

Descripción del empleo

Medtronic in Lafayette, CO or Mounds View, MN seeks a Principal Regulatory Affairs Specialist to lead global regulatory strategies for the RST consumable portfolio. You will drive early development and lifecycle activities, align with cross-functional teams, and guide submissions for U.S.

and EU markets. You will collaborate with R&D, marketing, clinical, and operations to integrate regulatory considerations into product decisions and ensure compliant promotional practices.