Natalie Mansfield

Natalie Mansfield

quality & regulatory specialist

Natalie Mansfield is a mechanical engineer who serves as a quality and regulatory affairs consultant. She brings to her clients 3 years of action-packed product development experience in orthopedic medical devices, including leading and supporting two product launches at two companies.

While at a start-up specializing in orthopedic medical devices for children, Natalie directed a development team right out of school to produce an FDA-cleared pediatric femoral plating system. She was blessed to wear multiple hats and learn the broad functions of a medical device company throughout the entire lifecycle of a development project. Along with project management, she gained experience in the full design and development process, including execution of a design history file and risk management file, defining user and design requirements, design for manufacturability, product design, verification and validation testing, design transfer, and regulatory submissions. At the other extreme of company size, Natalie honed skills in testing, inspection, manufacturing, and supplier relations at a multimillion dollar orthopedic company.

Natalie brings her strong technical writing, medical device development expertise, organizational skills, and hunger to the regulatory space. She has already been successful in authoring content for PMA submissions and Q-Submissions while complying with submission requirements and expectations. She is currently gaining experience in urologic devices, neurological prostheses, and neurological drug delivery.

Natalie lives in Winona Lake, Indiana with her husband, Micah. They devote their time to serving the Lord with their local church, playing pickleball, crafting, and spending time with friends and family.

For more information, please see her LinkedIn profile.