Regulatory Affairs Director

2 weeks ago

San Diego, CA, United States Truvian Sciences Full time
About Truvian
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
  • Bachelor's degree in Life Sciences, Engineering, or a related discipline required; advanced degree (MS, PhD) strongly preferred.
  • 12+ years of experience in Regulatory Affairs, with a minimum of 8 years in the IVD industry.
  • Proven success leading and managing FDA 510(k) and CLIA Waiver submissions and approvals; experience with De Novo submissions is a plus.
  • In-depth knowledge of U.S. FDA regulations, CLIA requirements, EU IVDR, ISO 13485, and other global regulatory standards relevant to IVDs.
  • RAC certification preferred (U.S., Global, or EU).
  • Demonstrated ability to translate complex regulatory guidance into practical regulatory strategies.
  • Experience interfacing with regulatory bodies, including preparation for and participation in agency meetings and audits.
  • Strong organizational, project management, technical, and analytical skills, with a high level of attention to detail.
  • Exceptional verbal and written communication skills, including the ability to influence and lead cross-functional teams.
  • Proficiency in Microsoft Office Suite; experience eQMS required.

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:
  • Impactful Mission: Join a passionate team revolutionizing point-of-care blood diagnostics and making a tangible difference in healthcare access.
  • High-Energy Environment: Thrive in a fast-paced, high-growth startup that values innovation, collaboration, and purpose.
  • Comprehensive Benefits Package, including:
    • Medical, Dental, Vision, and Life Insurance
    • Flexible Paid Time Off (PTO) and Paid Parental Leave
    • 401(k) plan with generous company match
  • Wellness Perks:
    • On-site gym and fitness classes
    • Access to a farm-to-table café with a 30% employee discount
    • Kombucha, cold brew, and healthy snacks are always on tap

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
  • Ability to lift and move up to 5 lbs.
  • Frequently standing and sitting for long periods.
  • Visual requirements include close, distance, color, peripheral, and depth perception.

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.

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