Director of Quality and Regulatory Affairs

Who We Are

At Leviant, we are committed to creating a safer, cleaner world through our innovative UV sanitization solutions. Our cutting-edge technologies provide fast, effective, and sustainable indoor sanitization, protecting people in healthcare, hospitality, education, and other industries. As we grow rapidly, we're looking for driven and intelligent professionals to join our team and make an impact.

The Role

The Director of Quality and Regulatory Affairs will be Leviant’s first internal leader for quality and regulatory affairs and will own the function end-to-end.

The first 18 months will center on two priorities

• Build Leviant’s Quality Management System from the ground up, creating a practical, scalable system aligned with FDA and ISO requirements.
• Lead the FDA regulatory pathway for Space-1, from regulatory strategy and testing through submission and clearance.

Leviant works with outside regulatory and quality consultants and expects to continue doing so. Those partners will provide specialized expertise and execution support, but this role will own the strategy, scope their work, evaluate recommendations, and remain accountable for the outcome.

Space-1 is the first regulatory initiative, not the last. As Leviant expands its device portfolio, this leader will build the systems, processes, and eventually the team required to support our growing company.

What You’ll OwnQuality Management System

• Design, implement, and maintain Leviant’s QMS in alignment with FDA Quality Management System Regulation requirements and ISO 13485.
• Establish core quality processes, including:
• Design controls
• Document and record control
• CAPA
• Nonconformance
• Change control
• Risk management
• Training and competency
• Management review
• Establish and maintain design history files and supporting technical documentation for Space-1 and future products.
• Build systems that are appropriately rigorous for a regulated device company while remaining practical for an early-stage organization.
• Prepare Leviant for FDA inspections, certification activities, and third-party audits.

Regulatory Strategy and Submissions

• Develop and own regulatory strategy for Space-1 and future Leviant products.
• Lead FDA submissions from strategy through clearance, including:
• Regulatory pathway assessment
• Predicate and competitive analysis
• Testing and evidence strategy
• Submission preparation and authoring
• Responses to FDA questions and requests for additional information
• Manage external regulatory consultants and specialized testing partners.
• Provide regulatory review of product labeling, claims, marketing materials, and clinical or scientific communications.
• Monitor changes in FDA requirements, consensus standards, and other regulations relevant to Leviant’s products.
• Serve as Leviant’s primary regulatory contact with FDA and other applicable regulatory bodies.

Supplier and Manufacturing Quality

Leviant manufactures through external contract manufacturing partners. This role will own manufacturing quality oversight.

Responsibilities include

• Qualify and monitor contract manufacturers and critical suppliers.
• Establish supplier quality agreements and appropriate supplier controls.
• Define incoming inspection, acceptance, and release requirements.
• Manage supplier nonconformances, deviations, investigations, and corrective actions.
• Oversee manufacturing process validation and quality-related production changes.
• Ensure appropriate traceability, documentation, and manufacturing records are maintained.

Post-Market Quality and Compliance

• Establish and manage complaint handling and post-market surveillance processes.
• Own Medical Device Reporting and other applicable adverse-event reporting processes.
• Establish recall, correction, and field-action procedures and readiness.
• Develop quality metrics and lead management review.
• Report quality and regulatory risks, trends, and priorities to company leadership and the board as appropriate.

What We’re Looking For

Required

• Bachelor’s degree in engineering, life sciences, or another relevant technical discipline.
• 7+ years of experience in medical device quality and/or regulatory affairs.
• Direct experience leading at least one FDA medical device submission through clearance or approval, such as a 510(k), De Novo, or PMA.
• Hands-on experience building, implementing, or substantially rebuilding a medical device QMS.
• Strong working knowledge of FDA QMSR / 21 CFR Part 820, ISO 13485, and ISO 14971.
• Experience overseeing outsourced or contract manufacturing from a quality perspective.
• Demonstrated ability to independently manage complex regulatory and quality projects.

Strongly Preferred

• Experience with Class II medical devices.
• Experience in a startup, emerging-growth company, or similarly resource-constrained environment.
• Experience with electromechanical products.
• Experience managing outside regulatory consultants, laboratories, and other technical partners.
• Familiarity with UV-C, infection prevention, environmental disinfection, or healthcare technology.
• RAC, CQE, CQA, or similar professional certification.

How You Work

• You are a builder. You are comfortable creating systems where none currently exist.
• You can operate independently. You may initially be the company’s primary internal expert in this domain.
• You exercise sound judgment. You know when a process needs rigor and when unnecessary complexity will slow the business without improving compliance.
• You can hold the line when necessary. You are comfortable identifying regulatory or quality risks and influencing commercial, engineering, and operational teams accordingly.
• You communicate clearly. You can translate regulatory requirements into practical actions for people who are not regulatory experts.
• You write exceptionally well. Your documentation must be clear, defensible, and able to withstand external scrutiny.
• You think beyond the next submission. You build systems that can support multiple products, increasing regulatory complexity, and future team growth.

Pay: $100.00 - $175.00 per hour

Expected hours: 20.0 – 25.0 per week

Work Location: Remote