Regulatory Affairs Technical Lead

Real Staffing; San Francisco (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Real Staffing is partnered with a digital health medical device company seeking a Regulatory Affairs Technical Lead to own regulatory strategy across development programs and collaborate with Product, Clinical, Quality, and Engineering teams to bring innovative AI-enabled SaMD technologies to market.

Ideal candidates have 8+ years in regulatory affairs for medical devices, with proven success in FDA submissions (510(k), De Novo, Pre-Submissions) and SaMD/AI/ML products.

Qualifications

• 8+ years of Regulatory Affairs experience in the medical device industry.
• Experience supporting SaMD, Digital Health, or AI/ML medical technologies.
• Led FDA submissions (510(k), De Novo, Pre-Submission activities).
• Strong understanding of FDA regulations, software validation, and design controls.

Responsibilities

• Own regulatory strategies for SaMD products and launches.
• Lead planning, authoring, and execution of FDA submissions.
• Serve as regulatory lead for new product development activities.
• Collaborate with cross-functional teams on regulatory impact of design changes and updates.
• Provide expertise on FDA requirements, software validation, and digital health regulations.
• Support audits, quality system activities, and post-market regulatory compliance.

Skills

Regulatory strategy

FDA submissions

SaMD experience

AI/ML health tech

Cross-functional lead

Regulatory communications

Education

Bachelor's degree in Engineering or related field

Job description

Overview

Our client is a financially stable, revenue-generating Digital Health medical device company with a strong commercial foundation and an exciting pipeline of new products and technologies. As they continue to expand their Software as a Medical Device (SaMD) and AI-enabled portfolio, they are seeking a Regulatory Affairs Technical Lead to own and implement regulatory strategy across key development programs.

This is a highly visible role where you will serve as the regulatory subject matter expert, partnering closely with Product, Clinical, Quality, and Engineering teams to bring innovative technologies to market while navigating an evolving regulatory landscape.

What You'll Do

• Own and implement regulatory strategies for AI/ML-enabled Software as a Medical Device (SaMD) products and future product launches.
• Lead the planning, authoring, and execution of FDA submissions, including 510(k), De Novo, and Pre-Submissions.
• Serve as the regulatory lead for new product development activities, providing strategic guidance throughout the product lifecycle.
• Partner with cross-functional teams to assess regulatory impact of design changes, software updates, and AI/ML enhancements.
• Provide expertise on FDA regulatory requirements, software validation, quality systems, and emerging digital health regulations.
• Support audits, quality system activities, promotional review, and post-market regulatory compliance.

Why This Opportunity?

• Opportunity to own and drive regulatory strategy rather than simply execute established processes.
• Join a financially stable and growing Digital Health organization with positive revenue generation and a strong market presence.
• Work on cutting-edge AI/ML and Software as a Medical Device technologies that are transforming patient care.
• Influence multiple products and programs across a robust development pipeline.
• Collaborate with highly talented Product, Engineering, Clinical, and Leadership teams.
• Play a key role in shaping the future regulatory direction of the organization.

What We're Looking For

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, or a related technical discipline.
• 8+ years of Regulatory Affairs experience within the medical device industry.
• Significant experience supporting Software as a Medical Device (SaMD), Digital Health, connected health, or AI/ML-enabled medical technologies.
• Demonstrated success leading FDA regulatory submissions, including 510(k), De Novo, and Pre-Submission activities.
• Strong understanding of FDA regulations, software validation, design controls, and quality systems.
• Ability to translate complex technical concepts into clear regulatory strategies and submissions.
• Excellent communication and stakeholder management skills with the ability to influence cross-functional teams.

This is an exceptional opportunity for a regulatory leader who wants to own strategy, influence innovation, and play a critical role in bringing next-generation digital health technologies to market. You will join a successful organization with proven commercial traction, a strong financial foundation, and a growing pipeline of innovative products that will shape the future of healthcare.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, direct-hire employees may be eligible for client offered benefits such as medical, dental, and vision coverage, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com