Regulatory Affairs Engineer — Medical Device Registrations

American Orthodontics; Sheboygan (WI); On-site; USD 65,000 - 95,000; Full time

Job summary

American Orthodontics in Sheboygan, WI is seeking a Regulatory Submissions and Documentation Specialist to support engineering and product development teams in obtaining product registrations.

The role focuses on planning regulatory submissions, maintaining technical documentation, coordinating audits, and ensuring compliance with domestic and international standards; in-office position with strong writing and communication skills.

Qualifications

• Bachelor’s degree in a relevant field is required or desired.
• Experience with medical devices or other highly regulated industries is preferred.
• Demonstrated ability to lead multiple activities simultaneously and maintain attention to detail.

Responsibilities

• Support regulatory submissions and documentation for product registrations.
• Communicate with customers and regulatory agencies to support submissions.
• Create, manage, and organize technical documentation in a document control system.
• Respond to agency questions and prepare additional documentation as requested.
• Participate in audits and maintain current knowledge of regulations and standards.

Skills

Regulatory knowledge

Technical writing

Project coordination

Written and verbal communication

Education

Bachelor's degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or related field

Job description

American Orthodontics in Sheboygan, WI is seeking a Regulatory Submissions and Documentation Specialist to support engineering and product development teams in obtaining product registrations.

The role focuses on planning regulatory submissions, maintaining technical documentation, coordinating audits, and ensuring compliance with domestic and international standards; in-office position with strong writing and communication skills.