Regulatory Operations & Excellence Leader (Acute Care)

Medtronic; Lafayette (CO); On-site; USD 140,000 - 190,000; Full time

Job summary

Medtronic in Lafayette, Colorado is seeking a Senior Manager, Regulatory Operations and Excellence to lead Regulatory Operations, Regulatory Compliance, and Technical Communications for the ACM portfolio.

You will partner with Regulatory Affairs and cross-functional teams to drive operational excellence, implement automation and digital transformation, and ensure global regulatory compliance across product lifecycle, labeling, and documentation.

Qualifications

• Bachelor's degree and 7+ years in regulatory operations or related fields.
• Experience leading operational improvement initiatives in a complex, regulated industry.
• Experience implementing digital solutions and workflow optimization projects.

Responsibilities

• Lead Regulatory Operations, Regulatory Compliance, and Technical Communications teams for the ACM portfolio.
• Develop and execute a strategic roadmap for regulatory systems and operational capabilities.
• Drive automation and digital transformation to improve processes and governance.
• Establish metrics, dashboards, and reporting for regulatory performance and compliance.
• Oversee global regulatory programs including UDI, EUDAMED data management, and Notified Body interactions.
• Partner with cross-functional stakeholders to manage product lifecycle labeling and documentation.

Skills

Regulatory Operations Leadership

Regulatory Compliance

Process Automation

Cross-functional Leadership

Regulatory Systems

Education

Bachelor's degree in Science, Engineering, Business Administration, or related technical discipline

Job description

Medtronic in Lafayette, Colorado is seeking a Senior Manager, Regulatory Operations and Excellence to lead Regulatory Operations, Regulatory Compliance, and Technical Communications for the ACM portfolio.

You will partner with Regulatory Affairs and cross-functional teams to drive operational excellence, implement automation and digital transformation, and ensure global regulatory compliance across product lifecycle, labeling, and documentation.