Principal Regulatory Affairs Specialist

Medtronic; Lafayette, Mounds View (CO, MN); On-site; USD 120,000 - 160,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory leadership

Cross-functional collaboration

Regulatory strategy development

Regulatory submissions

Mentoring others

Education

Bachelor's degree

Advanced degree (MS/PhD)

Job description

A Day in the Life

We anticipate the application window for this opening will close on - 19 Oct 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

This position is located in Lafayette, CO or Mounds View, MN and supports Robotics Surgery Technologies (RST) in the Surgical Operating Unit.

The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the consumable product [CB2.1]portfolio within RST. This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities as well as supporting complex post-market release and sustaining change activities.

This position is suited for a high-performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business and portfolio goals, drives regulatory strategy, and contributes to critical project and business milestones. The role requires strong awareness of cross-functional and organizational initiatives and the ability to assess regulatory impact on business decisions.

The Pr. RAS regularly communicates with internal stakeholders to provide strategic input, share updates, and support informed decision-making. Serving as a regulatory subject matter expert and individually contributing leader, this role acts as a role model within the organization and may mentor or provide guidance to junior regulatory professionals or support staff as needed.

Position requires to be onsite 4 days per week in one of the following locations:

• Lafayette, CO
• Mounds View, MN

Responsibilities may include the following and other duties may be assigned.

• Lead and execute global regulatory strategies across the product lifecycle, including early development and business wind-down activities.
• Provide regulatory strategy input for early-stage development, including pathway assessment, classification, and data requirements.
• Serve as a strategic partner to R&D, marketing, clinical, operations, and leadership to integrate regulatory considerations into product and business decisions.
• Act as regulatory lead for advertising and promotional material review, providing strategic guidance on claims, risk communication, and compliant promotional approaches.
• Lead or oversee preparation of U.S. and EU regulatory submissions, and support submissions for global markets.
• Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities to ensure compliance and support business objectives.
• Monitor and interpret global regulatory requirements and changes, proactively communicating risks and opportunities to stakeholders.
• Support and lead regulatory agency interactions, audits, inspections, and CAPA activities, as appropriate.
• Develop and deliver regulatory training; mentor junior regulatory staff.

Must Have: Minimum Requirements

• Bachelor's degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience

Nice to Have

• Extensive experience in medical device regulatory affairs.
• Strong hands‑on experience with U.S. Class II and III medical devices, including applicable regulatory requirements and consensus standards.
• In‑depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993‑1.
• Proven experience authoring and leading U.S. regulatory submissions (e.g., 510(k), PMA, IDE) and EU Technical Documentation and change notifications.
• Demonstrated expertise in compiling and maintaining EU MDR Technical Documentation.
• Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets.
• Strong experience reviewing and advising on advertising and promotional materials for U.S. and EU markets.
• Demonstrated ability to develop and execute regulatory strategies that support business and product objectives.
• Collaborative, solution‑oriented professional with a strong focus on delivering value to stakeholders and the organization.

For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities.