Regulatory Affairs Specialist

Title: Regulatory Affairs SpecialistLocation: Schaumburg, ILHire Type: Direct HireTarget Salary Range: $75,000 - $90,000/year base

Job Summary:Under the supervision of the Director of Regulatory Affairs, this role is responsible for supporting the preparation of regulatory 510(k) submissions, as well as assisting international business partners in Latin America, Asia, and Europe with product registrations, among other duties related to the regulatory compliance of Class I Medical Devices.

Job Duties:Author 510(k) submissions in the US FDA electronic system for Class I Medical Devices.Review and approve promotional materials and labeling for impact to product classification and 510(k)’s.Under supervision - Coordinate, compile, and submit regulatory applications to competent authorities, notified bodies, regulatory agencies, and international business partners, including the preparation of key market international documents, including technical files and 510(k)’s.Work with the Director of Regulatory Affairs to ensure rapid and timely approval of new and continued regulatory support of products marketed within and outside the United States, including labeling guidance and adequate deliverables required for technical file and US FDA requirements.Evaluate proposed product modifications for domestic and international regulatory impact, completing regulatory assessments as needed in change control process.Ensure compliance with applicable US and international regulations and standards.Oversee MDR and complaints; submit adverse events to the US FDA and assess impact to other markets.Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.Additional related duties.

Qualifications:Bachelor's Degree in Science or a Medical / Healthcare related field preferred.Must have experience authoring 510(k) submissions in the US FDA electronic system.Regulatory and/or Quality experience with US-regulated Class I Medical Devices.Working knowledge of Regulatory Authority computerized submission systems in ESG portal.Excellent written and verbal communication skills.Must reside within a commutable distance from Schaumburg, IL and be available to work onsite daily.