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Senior Regulatory Affairs Lead Medical Devices & AI​/ML

Job in Raleigh, Wake County, North Carolina, 27601, USA
Listing for: Align Technology, Inc.
Full Time position
Listed on 2026-10-06
Job specializations:
  • IT/Tech
Salary/Wage Range or Industry Benchmark: 160000 - 210000 USD Yearly USD 160000.00 210000.00 YEAR
Job Description & How to Apply Below
Position: Senior Regulatory Affairs Lead for Medical Devices & AI/ML

Align Technology, Inc. in Raleigh, NC seeks a Sr. Manager, Regulatory Affairs to drive regulatory strategy for diagnostic devices, including SiMD and SaMD. You will coordinate with product teams through lifecycle and craft strong submissions to health authorities.

The role requires 10+ years in medical device regulatory affairs, expert US FDA knowledge, and the ability to influence regulators. Ex-health authority experience is highly desirable, and mentoring is expected.

This role, Senior Regulatory Affairs Lead for Medical Devices & AI/ML at Align Technology, Inc., could be your next opportunity.

If your experience matches this role, we encourage you to apply.

All applications are reviewed carefully by our team.

The position is based in Raleigh, NC, United States.

This opportunity is part of our work in Legal, Management & Operations.

The advertised compensation is 160..

Position Requirements
10+ Years work experience
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