Senior Regulatory Strategy Lead – Medical Devices

Medtronic plc; Mounds View (MN); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Medtronic plc in the United States is seeking a Principal Regulatory Affairs Specialist to provide regulatory leadership for the Robotics Surgery Technologies portfolio in the Surgical Operating Unit. The role requires strategic thinking and cross-functional collaboration.

You will lead global submissions (US/EU), advise on labeling and advertising, mentor junior staff, and interact with authorities to ensure compliance across lifecycle.

Qualifications

• Bachelor’s degree required; 7+ years of experience or 5+ years with advanced degree.
• Extensive medical device regulatory affairs experience.
• Strong knowledge of US Class II/III requirements and EU MDR.
• Proven ability to author and lead 510(k), PMA, IDE submissions.
• Experience with EU MDR Technical Documentation and change notifications.
• Experience in regulatory authority interactions.
• Ability to mentor junior staff.

Responsibilities

• Lead and execute global regulatory strategies across product lifecycle.
• Provide regulatory input for early-stage development.
• Partner with R&D, marketing, clinical, operations, leadership to integrate regulatory considerations.
• Lead advertising/promotional material reviews.
• Lead US and EU submissions; support global submissions.
• Recommend labeling, manufacturing, marketing changes for compliance.
• Monitor global regulatory changes; communicate risks.
• Support agency interactions, audits, CAPA.
• Develop and deliver regulatory training; mentor staff.

Skills

Regulatory strategy

US submissions

EU MDR & ISO

Leadership/mentoring

Advertising reviews

Cross-functional collaboration

Education

Bachelor's degree

Tools

EU MDR Documentation

Job description

Medtronic plc in the United States is seeking a Principal Regulatory Affairs Specialist to provide regulatory leadership for the Robotics Surgery Technologies portfolio in the Surgical Operating Unit. The role requires strategic thinking and cross-functional collaboration.

You will lead global submissions (US/EU), advise on labeling and advertising, mentor junior staff, and interact with authorities to ensure compliance across lifecycle.