Regulatory Affairs Analyst

Duties and Responsibilities

• Create, manage, and organize technical documentation in a document control system
• Communicate with customers and regulatory agencies to support product registrations
• Evaluate requests for information from various countries, then prepare documents to fulfill requests
• Manage projects related to maintaining product registrations in domestic and international markets
• Communicate as needed with engineering, quality, marketing, and other internal departments
• Write and/or update procedures to align with regulatory regulations and standards
• Maintain current knowledge base of relevant regulations and standards
• 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 Biology, Chemistry, Technical Communication, or a 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