Senior Regulatory Affairs Lead - Medical Devices (Remote)

USA-Medtronic MiniMed, Inc 1017; California; Remote; USD 120,000 - 150,000; Full time

Job summary

MiniMed, a global leader in diabetes care, seeks a Principal Regulatory Affairs Specialist to guide medical devices and software through US FDA, EU MDR, and other global pathways. You will lead regulatory strategies, interact with authorities, and shape submissions across US, EU, and international teams.

This 100% remote role offers collaboration across functions and travel up to 10%. Candidates should have extensive regulatory experience with Class II/III devices and proven success in global

Qualifications

• Minimum 7 years of medical device regulatory experience with Bachelor’s degree.
• Or minimum 5 years of medical device regulatory experience with an advanced degree.
• History of successful device submissions in the US and EU for Class II and Class III devices.
• Knowledge of FDA requirements, EU MDR, ISO 14971, ISO 13485 and related standards.

Responsibilities

• Develop and refine regulatory strategies to support innovations across US, EU and global teams.
• Lead submissions for drug delivery devices and related software.
• Apply regulatory standards to product strategies and submissions.
• Lead negotiations with regulatory authorities to secure approvals/clearances.
• Provide regulatory input to product lifecycle planning and cross-functional teams.
• Manage communications with regulatory agencies and provide pre-submission guidance.

Skills

Regulatory strategy

Regulatory submissions

Project management

Stakeholder communication

Education

Bachelor's degree

Advanced degree

Tools

MS Office

MS Project

Adobe Acrobat

Job description

MiniMed, a global leader in diabetes care, seeks a Principal Regulatory Affairs Specialist to guide medical devices and software through US FDA, EU MDR, and other global pathways. You will lead regulatory strategies, interact with authorities, and shape submissions across US, EU, and international teams.

This 100% remote role offers collaboration across functions and travel up to 10%. Candidates should have extensive regulatory experience with Class II/III devices and proven success in global