Principal Regulatory Strategy Lead, Medical Devices

Regulatory Jobs; Lafayette (CO); On-site; USD 120,000 - 180,000; Full time

Job summary

Medtronic in the United States is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies for the Robotics Surgery Technologies portfolio. You will collaborate with R&D, marketing, clinical, and operations to shape regulatory pathways from early development through lifecycle management, ensuring compliant submissions in the U.S.

and EU while aligning with business objectives. This role requires strong leadership, strategic thinking, and the ability to mentor junior

Qualifications

• Bachelor’s degree required.
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
• Experience in medical device regulatory affairs, US and EU submissions.
• Ability to lead regulatory strategy across product lifecycle.

Responsibilities

• Lead and execute global regulatory strategies across the product lifecycle, including early development and wind-down.
• Provide regulatory strategy input for early-stage development, including pathway assessment and data needs.
• Partner with R&D, marketing, clinical, operations and leadership to integrate regulatory considerations.
• Lead regulatory review for advertising and promotional materials and ensure compliant approaches.
• Prepare and oversee U.S. and EU regulatory submissions and support global submissions.
• Recommend changes to labeling, manufacturing, marketing and clinical activities to ensure compliance.
• Monitor global regulatory requirements and communicate risks and opportunities to stakeholders.
• Support agency interactions, audits, inspections, and CAPA activities; mentor staff.
• Develop and deliver regulatory training; mentor junior regulatory staff.

Skills

Regulatory leadership

Regulatory strategy

Cross-functional collaboration

Strategic input

Education

Bachelor’s degree

Advanced degree

Job description

Medtronic in the United States is seeking a Principal Regulatory Affairs Specialist to lead global regulatory strategies for the Robotics Surgery Technologies portfolio. You will collaborate with R&D, marketing, clinical, and operations to shape regulatory pathways from early development through lifecycle management, ensuring compliant submissions in the U.S.

and EU while aligning with business objectives. This role requires strong leadership, strategic thinking, and the ability to mentor junior