Prepare and submit FDA/CDRH reports for new laser products, product modifications, and manufacturing location changes.
Manage and maintain all accession numbers and ensure accurate linkage to product records.
Compile, validate, and submit the annual FDA report covering all applicable Coherent products worldwide.
Environmental Compliance
Support company-wide compliance with global environmental regulations including: - RoHS, REACH, WEEE, Waste Framework Directive (WFD), PFAS, Prop 65, TSCA
Collaborate with third‑party service providers to leverage their tools and services for acquiring required documentation and data to support compliance efforts.
Maintain support and control environmental compliance documentation, such as certificates, product declarations and technical files and ensure files are current, accurate, and complete.