Global Regulatory Strategy Lead (Medical Devices & SaMD)

Abbott; Los Angeles (CA); On-site; USD 150,000 - 190,000; Full time

Job summary

Abbott seeks a Senior Regulatory Affairs Manager to lead global regulatory strategy and submissions for the Digital Solutions team, on-site in Sylmar, CA or Santa Clara, CA. You will guide regulatory thinking, ensure compliance with FDA, EU MDR, ISO 13485, and related regulations, and drive product lifecycle activities.

The role requires mentoring regulatory staff, coordinating with cross-functional teams, and engaging with regulators to enable market access and continued product success.

Job description

Abbott seeks a Senior Regulatory Affairs Manager to lead global regulatory strategy and submissions within our Digital Solutions team on-site in Sylmar, CA or Santa Clara, CA. You will guide regulatory thinking, ensure compliance with FDA, EU MDR, ISO 13485, and related regulations, and drive product lifecycle activities.

The role requires mentoring regulatory staff, coordinating with cross-functional teams, and engaging with regulators to enable market access and continued product success.