Job Description
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/or ...