Global Director, Regulatory Operations & Strategy

COV Covidien LP; Lafayette (CO); On-site; USD 194,000 - 292,000; Full time

Benefits offered by this job

Health insurance

401(k) plan and matching

Paid time off

Employee Stock Purchase Plan

Job summary

Medtronic in the United States is seeking a Director of Regulatory Affairs Operations to lead RA Ops, RF regulatory leadership, OEM/BD regulatory stewardship, and governance across the product lifecycle. The role reports to ACM RA leadership and manages a team in a global matrixed environment.

Responsibilities include strategy development, data governance, and regulatory compliance programs, with a focus on speed, quality, and patient safety across markets.

Qualifications

• Bachelor’s degree and 10+ years in regulatory, quality, or related fields with 7+ years in management.
• Experience leading regulatory affairs in a global, matrixed environment.
• Ability to align business priorities with regulatory strategy and lifecycle management.
• Proven experience managing cross-disciplinary teams and external partners.

Responsibilities

• Lead the RA Operations strategy and roadmap for ACM Regulatory Affairs.
• Oversee regulatory information management, product lifecycle, dashboards, and planning tools.
• Drive automation and AI-enabled improvements in regulatory delivery.
• Provide strategic leadership for radiofrequency regulatory requirements and governance.
• Manage OEM regulatory stewardship and BD/L regulatory activities.
• Ensure regulatory compliance programs and governance across ACM RA.
• Develop and lead a diverse regulatory team and stakeholder relationships.

Skills

Regulatory leadership

Regulatory affairs

Cross-functional leadership

Quality systems

Education

Bachelor’s degree

Advanced degree

Tools

Regulatory operations systems

Data governance

Automation tools

Job description

Medtronic in the United States is seeking a Director of Regulatory Affairs Operations to lead RA Ops, RF regulatory leadership, OEM/BD regulatory stewardship, and governance across the product lifecycle. The role reports to ACM RA leadership and manages a team in a global matrixed environment.

Responsibilities include strategy development, data governance, and regulatory compliance programs, with a focus on speed, quality, and patient safety across markets.