Regulatory Affairs Engineer​/Specialist

Job Posting

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

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 This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.