Regulatory Affairs Director

Regulatory Affairs Director

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 companywe'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 : 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 needsnever based on race, color, religion, gender, gender identity or expression, sexual orientation, national origin, disability, age, or veteran status.