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.
- • 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
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.