Senior Regulatory Affairs Lead - Medical Devices & SaMD

Thornton Tomasetti; California; On-site; USD 131,000 - 261,000; Full time

Job summary

Abbott Laboratories seeks a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will lead regulatory submissions and guide cross-functional teams through FDA and EU pathways for SaMD and medical devices.

The role requires 9+ years in regulatory affairs, strong QMS experience, and the ability to work across global regions with a focus on lifecycle management and post-market activities.

Qualifications

• Bachelor's degree in a scientific or engineering field or equivalent.
• Experience preparing PMA/IDE submissions, 510(k)s and EU submissions.
• Experience with FDA/Notified Bodies and global regulatory pathways.

Responsibilities

• Lead global regulatory submissions and agency interactions.
• Develop and implement regulatory strategies for product lifecycle.
• Ensure compliance with FDA, EU MDR/CE, ISO 13485 and other regs.
• Mentor regulatory staff and drive cross-functional collaboration.

Skills

Regulatory strategy

PMA submissions

510(k) submissions

EU MDR

FDA interactions

QMS

Mentoring

Education

Bachelor's degree

Master’s in regulatory affairs

Job description

Abbott Laboratories seeks a Senior Regulatory Affairs Manager for Digital Solutions, on-site in Sylmar, CA or Santa Clara, CA. You will lead regulatory submissions and guide cross-functional teams through FDA and EU pathways for SaMD and medical devices.

The role requires 9+ years in regulatory affairs, strong QMS experience, and the ability to work across global regions with a focus on lifecycle management and post-market activities.