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/or revise product content material declarations as needed to support new product development and changes in worldwide environmental regulations
• Develop accurate and timely customer responses to inquiries regarding material contents and compliance for various applicable world-wide hazardous material regulations
• Partners with internal and external Coherent Corp. suppliers to obtain all required product sub-assembly and component material content data evaluate and interpret content declarations and conduct confirming analysis and experimentation where needed

Others

• Customer surveys compliance entities requests (IntegrityNext ECO Vadis etc.)

Requirements

• Bachelor degree Material Science Environmental Engineering or related discipline
• 2-3 years industry experience in RoHS / REACH and related environmental regulations.
• Experience in the computer telecommunications optics or similar tech-industries a plus

Special Skills

• Independent. Able to complete assigned tasks in a timely manner with minimal direction
• Accurate. Excellent attention to detail. Organized
• Proactive. Customer-service focus. A passion for excellence
• Flexible within a dynamic environment. Able to multi-task and reprioritize as needed
• Ownership of an issue or project to resolution. Reliable follow-up and follow-through as needed
• Team Player. Able to collaborate with team members around the world
• Analytical approach to problem solving. Critical thinker. Uses data to substantiate decision making
• Understands the scope and applicability of global environmental directives and regulations
• Strong written and verbal English skills

Working Conditions

• This role is onsite

CultureCommitment

Ensure adherence to companys values (ICARE) in all aspects of your position at Coherent Corp.:

Integrity Create an Environment of Trust

Collaboration Innovate Through the Sharing of Ideas

Accountability Own the Process and the Outcome

Respect Recognize the Value in Everyone

Enthusiasm Find a Sense of Purpose in Work