Regulatory Affairs Director

Truvian Regulatory Affairs Director

Truvian is a fast-paced, disruptive healthcare company at the intersection of diagnostics and consumer technology. We're building a fully automated, benchtop diagnostic system that delivers lab-accurate results from a small blood sample in just 30 minutes. Designed for retail clinics and private practices, our platform is currently undergoing FDA review and aims to revolutionize routine blood testing by making it more accessible, affordable, and actionable.

At Truvian, our mission goes beyond the lab. We are committed to empowering individuals with timely health data and fostering a culture of innovation, collaboration, and discovery. Join us and help realize our vision of transforming routine health testing for today's connected consumers.

Position Summary

Truvian is seeking an experienced and hands-on Regulatory Affairs Director to lead and execute all aspects of the company's global regulatory strategy. This leadership role will be responsible for supporting regulatory submissions and product registrations across domestic and international markets, ensuring compliance with applicable regulations, and enabling timely product commercialization.

The ideal candidate must have extensive experience in the in vitro diagnostics (IVD) industry, with a strong track record of leading both FDA 510(k) and CLIA Waiver submissions through to successful clearance. This individual will work cross-functionally with internal stakeholders, regulatory bodies, and international partners to ensure our technology meets all applicable requirements while aligning with Truvian's mission to transform diagnostic testing.

This position is onsite and reports to the Head of Quality & Regulatory. This is a high-impact, hands-on role based at our corporate headquarters in San Diego, California.

Key Responsibilities

• Support the regulatory strategy for Truvian's portfolio of IVD products, ensuring proactive planning and timely execution of submissions to FDA (510(k), CLIA Waiver), Health Canada, European Notified Bodies (CE Mark / IVDR), and other international agencies.
• Support the end-to-end regulatory submission process, including the development of submission dossiers, gap assessments, pre-submissions, and agency interactions.
• Work with the regulatory team to ensure a comprehensive regulatory roadmap aligned with product development and commercialization milestones.
• Provide regulatory guidance during all phases of product development, from concept through design transfer, clinical validation, and market launch.
• Ensure all product documentation, including labeling, advertising, and promotional materials, meets regulatory requirements.
• Interpret and communicate complex regulatory requirements to internal stakeholders in a clear and actionable manner.
• Support regulatory impact assessments of product and process changes; oversee documentation updates and change control.
• Monitor and implement evolving global regulatory requirements (e.g., IVDR transition, ISO 13485 updates) and translate them into internal strategies and processes.
• Support post-market regulatory activities, including vigilance reporting, field actions, and annual reporting obligations.
• Collaborate with OEMs, distributors, and international partners to align global regulatory strategies and support international market entry.

Required Qualifications

What You'll Love About Working Here

At Truvian, we're more than just a diagnostics company we're a mission-driven team committed to transforming the way people access and experience blood testing. Here's what makes working with us truly special :

Supervisory Role

No

Travel Requirements

May require up to 10% travel

FLSA

Exempt

Work Location

Onsite

Salary Range

$168,000 - $186,000 This range considers the wide range of factors that are considered in making compensation decisions, including but not limited to experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. Salary offers are determined based on final candidate qualifications and experience. Placement within the compensation range is determined by level, band, internal equity, and relevant qualifications.

Physical Demands

Application Instructions

We want to hear your story! To apply, please submit your resume and a cover letter outlining your experience and what excites you about joining Truvian.

Equal Opportunity Employer

Truvian is an Equal Opportunity Employer. We are committed to building a diverse and inclusive team where everyone belongs and thrives. All employment decisions are made based on qualifications, merit, and business needs never based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.