Summary

American Orthodontics (AO) is a leading global manufacturer of orthodontic treatment supplies and dental devices, founded in 1968 and headquartered in Sheboygan, Wisconsin. As the largest privately held orthodontic manufacturer in the world, the company specializes in producing high-quality orthodontic products including braces, brackets, wires, and related treatment supplies. With over 700 global employees and product availability in more than 110 countries, AO operates a state-of-the-art 280,000 square foot manufacturing facility where 98% of its products are manufactured using advanced technologies such as powdered metal injection molding, CNC machining, 3D printing, and laser welding. The company maintains 14 wholly owned subsidiaries and a direct sales force in North America, complemented by a global network of exclusive distributors. American Orthodontics is renowned for its commitment to quality, dependable delivery, and personalized service to orthodontic specialists worldwide, while also being a major supporter of orthodontic education as the only Platinum Corporate Partner of the American Association of Orthodontists Foundation with a $1 million donation commitment.

Job description

Duties and Responsibilities

Support Engineering and Product Development teams to successfully complete and obtain product registrations
Determine the types of regulatory submissions or documentation required for projects with product design changes, manufacturing changes, or labeling changes
Advise project teams on subjects such as pre-market regulatory requirements, export and labeling requirements, and/or clinical study requirements
Communicate with customers and regulatory agencies to support product registrations
Create, manage, and organize technical documentation in a document control system for domestic and international registrations
Respond to questions from regulatory agencies and prepare additional documentation as requested
Manage projects related to maintaining product registrations in domestic and international markets
Support product vigilance activities through review of customer complaints, reportable incident databases, and clinical literature
Identify relevant guidance documents, international standards, or consensus standards and ensure these are communicated through corporate policies and procedures
Write and/or update Quality Management System procedures, standard operating procedures, and/or work instructions to align with domestic or international laws, guidelines, or standards
Maintain current knowledge base of relevant regulations, international standards, and/or guidance documents
Participate in internal and external audits
Perform additional responsibilities as requested to achieve business objectives
This position is 100% in-office in Sheboygan, WI

Qualifications

Bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar field from an accredited college or university desired
Experience with medical devices or other highly regulated industries/products desired
Experience with technical writing desired
Demonstrated ability to lead multiple activities simultaneously
Demonstrated thoroughness and attention to detail
Strong written and verbal communication skills

Requirements

Bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar field from an accredited college or university desired
Experience with medical devices or other highly regulated industries/products desired
Experience with technical writing desired
Demonstrated ability to lead multiple activities simultaneously
Demonstrated thoroughness and attention to detail
Strong written and verbal communication skills

Company overview

American Orthodontics (AO) is a leading global manufacturer of orthodontic treatment supplies and dental devices, founded in 1968 and headquartered in Sheboygan, Wisconsin. As the largest privately held orthodontic manufacturer in the world, the company specializes in producing high-quality orthodontic products including braces, brackets, wires, and related treatment supplies. With over 700 global employees and product availability in more than 110 countries, AO operates a state-of-the-art 280,000 square foot manufacturing facility where 98% of its products are manufactured using advanced technologies such as powdered metal injection molding, CNC machining, 3D printing, and laser welding. The company maintains 14 wholly owned subsidiaries and a direct sales force in North America, complemented by a global network of exclusive distributors. American Orthodontics is renowned for its commitment to quality, dependable delivery, and personalized service to orthodontic specialists worldwide, while also being a major supporter of orthodontic education as the only Platinum Corporate Partner of the American Association of Orthodontists Foundation with a $1 million donation commitment.