Regulatory Affairs Engineer/Specialist

American Orthodontics; Sheboygan (WI); Hybrid; USD 65,000 - 90,000; Full time

Job summary

American Orthodontics in Sheboygan, WI seeks a Regulatory Affairs professional to support engineering and product development in obtaining product registrations and maintaining compliant documentation.

The role requires determining submission types, advising on pre-market and labeling requirements, managing domestic and international registrations, and supporting audits while coordinating with customers and regulatory agencies. This is a full-time, in-office position in Wisconsin.

Qualifications

• Bachelor’s degree in a relevant STEM field from an accredited college or university.
• Experience with medical devices or other highly regulated industries/products is desirable.
• Experience with technical writing is desirable.
• Ability to lead multiple activities simultaneously.
• Strong written and verbal communication skills.

Responsibilities

• Support Engineering and Product Development to obtain product registrations.
• Determine regulatory submission requirements for design/manufacturing/labeling changes.
• Advise on 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.

Skills

Strong written and verbal comms

Leadership of multiple activities

Attention to detail

Education

Bachelor’s degree in Biomedical Engineering, Biology, Chemistry, Technical Communication, or similar

Job description

• 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

Equal Opportunity Employer

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