Regulatory Affairs Engineer/Specialist

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

Corporate
3524 Washington Avenue
Sheboygan, WI 53081, USA

Corporate
3524 Washington Avenue
Sheboygan, WI 53081, USA

• 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

Qualifications

Skills

Behaviors

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Motivations

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Education

Experience

Licenses & Certifications

Equal Opportunity Employer
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