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Ortho2 is the leading provider of practice management, imaging, and communication software to orthodontic professionals.

Open positions: Quality Assurance and Regulatory Affairs Manager


Quality Assurance and Regulatory Affairs Manager

Ortho2 is seeking a Quality Assurance and Regulatory Affairs Manager to be based in Ames, Iowa, who will be responsible for planning, directing, and/or coordinating quality and regulatory processes for certain components of our orthodontic software practice management suite of products.

Duties and Responsibilities include, but are not limited to:

  • • Manage the FDA-QSR and ISO 13485 quality system requirements
  • • Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards
  • • Review and monitor controlled records supporting the QMS
  • • Ensure all quality assurance systems and processes are being adhered to
  • • Coordinate preparation for internal and external audits and inspections
  • • Designated Representative (deputy) per FDA-QSR quality system requirements; specifically;
  • • Ensure processes needed for the QMS are maintained and updated as needed
  • • Report to management on the performance of the QMS and any needs for improvement
  • • Ensure the promotion of awareness of regulatory requirements throughout the organization to any employees/stakeholders involved with the regulated products
  • • Coordinate Design Control activities as they relate to FDA-QSR and ISO
  • • Collaborate with internal teams to maintain and track standardized quality training for employees
  • • Ability to wear many “hats” in a small company environment where helping coordinate functions such as Design Control, technical report writing, and risk analysis will be needed
  • • Other duties as assigned

Minimum Education Requirements:

  • • Bachelor’s degree in science, engineering, or technical field preferred.

Job Requirements:

  • • 2-3 years’ experience with Regulatory Affairs activities
  • • Knowledge of the FDA regulatory/quality processes and personal experience in working directly with regulatory and/or safety agencies (e.g., 510Ks, CE, UL, Notified Bodies, etc.)
  • • Experience with FDA, QSR quality systems requirements – ISO experience recommended
  • • Excellent interpersonal, written and verbal communication skills
  • • Experience with software-based product – medical/dental software desirable
  • • Strong computer skills for maintaining an electronic Quality System

Benefit Package:

Ortho2 offers an excellent benefits package, including medical, dental and prescription drug coverage. Paid time-off, short term and long term disability insurance, life insurance and a 401k/Roth plan with a generous company match. As well as the opportunity for a performance based, year-end bonus.


Benefits Summary

Quality Assurance and Regulatory Affairs Manager