Regulatory Affairs Engineer/Specialist

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