Senior Regulatory Leader for AI/ML SaMD Diagnostic Devices

Align Technology, Inc.; Morrisville (NC); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Health benefits

Paid vacation

Parental leave

401k match

Job summary

Align Technology, Inc. is seeking a Sr. Manager, Regulatory Affairs to lead regulatory strategy for diagnostic devices, SiMD and SaMD, across the product lifecycle in the US.

You will interface with Health Authorities, guide risk management, and influence policy in a dynamic regulatory landscape. The role requires deep US regulatory knowledge, leadership, and a track record with AI/ML-enabled medical devices, with collaboration across cross-functional teams to drive compliant, innovative

Qualifications

• 10+ years of experience in regulatory affairs, quality, device development or related field in the medical device industry.
• Extensive experience with diagnostic SaMD products, AI/ML-enabled SaMD products, headless products, and US FDA regulations/guidance and global standards.
• Ex-health authority regulatory experience is highly desirable.
• Demonstrated success in developing strong working relationships with regulators and external groups to influence effectively and bring about consensus on policies that support business objectives.

Responsibilities

• Develop and implement regulatory strategies for diagnostic devices including physical devices, SiMD and SaMD.
• Lead the effort to solve technical and strategic challenges with broad impact on the diagnostic device portfolio.
• Articulate potential regulatory scenarios and the associated risks/mitigations and recommend a path forward.
• Monitor external regulatory trends, including AI/ML initiatives, to anticipate risks and implement regulatory measures.
• Act as RA SME in assigned area and contribute to RA department priorities.
• Serve as the regulatory subject matter expert for deploying AI/ML-enabled functions across products and promote emerging regulatory tools.
• May support global submission activities and regulatory compliance or operation activities as assigned.

Skills

Regulatory strategy

Leadership

Risk management

AI/ML regulatory

Regulatory intelligence

Education

Bachelor's degree in engineering/regulatory affairs

Job description

Align Technology, Inc. is seeking a Sr. Manager, Regulatory Affairs to lead regulatory strategy for diagnostic devices, SiMD and SaMD, across the product lifecycle in the US.

You will interface with Health Authorities, guide risk management, and influence policy in a dynamic regulatory landscape. The role requires deep US regulatory knowledge, leadership, and a track record with AI/ML-enabled medical devices, with collaboration across cross-functional teams to drive compliant, innovative