Description
The Regulatory Affairs Specialist will prepare and submit FDA/CDRH reports for laser products, manage accession numbers and regulatory records, advise engineering and business teams on FDA requirements, serve as the official correspondent with FDA/CDRH, and support audits and compliance reviews. The role requires a bachelor’s degree in a relevant technical field, at least three years of regulatory compliance or FDA-related reporting experience, familiarity with laser or similar regulated technologies, and strong documentation and communication skills. Experience with FDA submission systems, photonics or laser-device industries, environmental compliance, EMI/EMC frameworks, and regulatory credentials is preferred. The position is onsite.
