Senior Manager, Regulatory Affairs

Job overview

The Senior Manager, Regulatory Affairs role is onsite in Morrisville, NC, with a stated base salary range of $139,700–$192,100 per year. The position supports Align Technology’s diagnostic device portfolio, including physical devices and medical software. This role develops and executes regulatory strategies across the product lifecycle, advises on regulatory risks, supports submissions, and works with internal teams and health authorities to advance compliant product development and regulatory practices.

What you'll do

• Develop and implement regulatory strategies for diagnostic devices, including physical devices, software in medical devices, and software as a medical device. Advise on regulatory scenarios, risks, and mitigations
• monitor regulatory trends, including AI/ML initiatives
• support submissions and regulatory activities as assigned
• engage with health authorities and industry partners
• mentor cross-functional teams on regulatory strategy and risk management.

What we're looking for

Skills & competencies

senior manager

regulatory affairs

medical devices

diagnostic devices

samd

simd

ai/ml

morrisville nc

align technology

$139.7k–$192.1k/year

travel up to 10%

health authority engagement

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision plans
• 401(k) with company match
• employee stock purchase program
• paid vacation, sick time, and holidays
• parental and bereavement leave
• disability and life insurance
• family-forming benefits
• caregiving support
• employee assistance program.

Why this role

Strategic regulatory leadership for diagnostic devices and AI/ML-enabled products, with external health-authority engagement and up to 10% domestic and international travel.

About the employer

Align Technology is hiring for this role. Industry: Dental Equipment and Supplies Manufacturing. Sector: 33.