FDA and Environmental Compliance Reporting Coordinator

Responsibilities

FDA Responsibilities

• 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.
• Create and/...