Quality Assurance & Regulatory Affairs Director
At Aerobiotix, we are on a mission to transform the safety of healthcare environments through innovative air quality technologies that reduce infection risk and improve patient outcomes. Our proprietary solutions eliminate airborne pathogens and deliver measurable, data-driven improvements in care settings worldwide.
We are a growing, entrepreneurial medical device company headquartered in Dayton, Ohio, seeking a Quality Assurance/Regulatory Affairs Director to lead and evolve our quality systems as we scale.
Why This Role Matters
Reporting to the President, you will lead the company’s Quality Management System and ensure compliance with FDA, ISO, and global regulatory standards. This is a highly visible role with direct impact on product quality, regulatory strategy, and company growth.
What You’ll Do
- Lead and continuously improve QA/RA processes aligned with ISO 13485, ISO 9001, and FDA 21 CFR 820
- Manage regulatory compliance activities, both domestic and international
- Serve as the Management Representative for the Quality System
- Oversee CAPA, risk management, FMEAs, complaint handling, and audits
- Prepare for and lead regulatory inspections
- Ensure robust design history records (DHR) and product compliance
- Establish and monitor quality metrics and performance trends
- Manage and mentor QA/RA team members
- Partner across departments to embed quality into every stage of product development and manufacturing
What We’re Looking For
- Bachelor’s degree plus 5+ years in medical device industry
- Deep expertise in ISO 13485 and ISO 9001 Quality Systems Management, as well as knowledge of FDA CFR 21 Part 820 Quality System Regulations for Medical Devices and Good Manufacturing Practices (GMPs)
- Experience in fast-paced, growth-oriented environments
- Strong leadership with ability to operate as both strategic leader and hands-on contributor
- Proven ability to interpret regulatory standards and drive compliance
- Excellent communication and cross-functional collaboration skills
Nice to have
- Experience with EN 60601, UL/ETL standards
- Exposure to international regulatory requirements
Why Join Aerobiotix?
- Mission-driven work improving patient safety
- Innovative, high-impact medical technology
- Growing team with strong leadership visibility
Apply Today: hr@aerobiotix.com
Equal Opportunity Employer
