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Sr Manager, Global Regulatory Affairs (AI/ML)

hims-and-hersUS RemotePOLICY
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Salary
$170K – $200K
Job type
Full-time
Work mode
Remote
Experience
Senior · 12+ yrs
Posted
25 Sept 2026
Status
Open · checked 7d ago

About this role

This role suits an experienced regulatory professional with a strong background in digital health and artificial intelligence who wants to manage global compliance strategies for software-based health products in a remote setting. The Senior Manager, Global Regulatory Affairs (AI/ML) position at Hims & Hers directs global regulatory strategy for software, machine learning solutions, and cybersecurity needs across domestic and international markets.

Role Overview

This remote position owns the global regulatory strategy for software and AI and machine learning enabled products. The professional helps internal teams understand regulatory requirements, identifies potential compliance risks, and establishes pathways to market new capabilities responsibly. Collaboration is required with Product, Engineering, Clinical, Quality, and Legal groups to guide early product strategy.

Key Responsibilities

Direct global regulatory strategy for software and machine learning enabled products across the United States and international markets.
Partner with cross-functional teams including Product, Engineering, Clinical, Quality, and Legal to shape strategy and manage high-priority projects.
Advise teams regarding digital health, cybersecurity, and artificial intelligence standards, translating policy updates into actionable recommendations.
Establish scalable governance frameworks for product changes, ongoing algorithm monitoring, software lifecycles, and cybersecurity.
Identify regulatory opportunities and risks early to support decision-making processes.
Monitor global regulatory developments continuously to position tech and growth strategies appropriately.

Requirements

Twelve or more years of experience in Regulatory Affairs with specialized knowledge in artificial intelligence, machine learning, and digital health.
Direct background interacting with the FDA and international regulatory agencies concerning complex software and machine learning solutions.
Thorough understanding of global regulatory standards covering software lifecycles, risk management, quality systems, cybersecurity, and artificial intelligence.
Capacity to evaluate risks and translate changing regulations into practical business advice.
Proven ability to communicate technical regulatory concepts to executive and cross-functional stakeholders.
Bachelor of Science or Master of Science degree in Computer Science, Biomedical Engineering, Software Engineering, Data Science, or a related field.

Nice to Have

Advanced degrees such as an MS, PhD, or JD.
Regulatory Affairs Certification (RAC).

Skills and Tools

Regulatory Affairs
Artificial Intelligence and Machine Learning (AI/ML) frameworks
Digital Health standards
Cybersecurity compliance
Software lifecycle and quality management systems
FDA engagement

Salary and Benefits

Salary ranging from $170K to $200K plus equity compensation.
Unlimited paid time off, company holidays, and quarterly mental health days.
Comprehensive medical, dental, vision, and parental leave benefits.
Employee Stock Purchase Program.
401(k) plan with employer matching.
Team offsite retreats.

About the Company

Hims & Hers functions as a public health and wellness platform traded on the NYSE under the ticker symbol HIMS. The organization focuses on affordable, accessible, and personalized healthcare solutions ranging from diagnosis to treatment and delivery.

How to Apply

To apply for this position, please visit the official company careers page.

Skills and tech stack

Questions candidates ask

What is the salary for the Senior Manager, Global Regulatory Affairs position?

The salary ranges from $170K to $200K, accompanied by equity compensation.

Where is the job located?

The position is a US Remote role.

What educational qualifications are needed?

A BSc or MSc in Biomedical Engineering, Computer Science, Data Science, Software Engineering, or a related field is required. Advanced degrees like an MS, PhD, JD, or RAC are valued.

How many years of experience are required?

Candidates must have 12 or more years of experience in Regulatory Affairs with a dedicated focus on digital health and artificial intelligence or machine learning.

What benefits are provided?

Benefits include unlimited PTO, quarterly mental health days, comprehensive medical, dental, and vision coverage, parental leave, an Employee Stock Purchase Program, 401(k) matching, and team offsite retreats.

Ready to apply?

The application is on the official hims-and-hers careers page.

Apply on company site