FDA and Environmental Compliance Reporting Coordinator

Key Responsibilities : 

Regulatory Reporting & Submissions

• 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.

 

Regulatory Expertise & Internal Support

• Serve as Coherent’s subject‑matter expert on FDA laser product regulations (21 CFR 1040, Laser Notice 56, etc.).
• Advise product engineering teams, Trade Compliance, and business units on regulatory requirements and reporting obligations.
• Provide guidance during product development to ensure compliance readiness prior to launch.

 

Centralized Documentation & Recordkeeping

• Maintain a centralized, audit‑ready repository of all FDA submissions, correspondence, certifications, and regulatory records.
• Ensure consistent documentation practices across all global Coherent sites.

 

FDA Correspondence & Communication

• Act as the official correspondent with FDA/CDRH for all inquiries, submissions, and follow‑up actions.
• Respond promptly to FDA requests, including urgent inquiries related to product releases or export certifications.
• Manage access and submissions through FDA systems such as esubmitter and ESG Next Gen gateway.

 

Compliance Oversight & Risk Mitigation

• Monitor regulatory changes and ensure Coherent’s processes remain aligned with FDA expectations.
• Identify compliance risks and recommend corrective actions or process improvements.
• Support internal audits, external inspections, and compliance reviews.

 

Qualifications :

Required

• Bachelor’s degree in Engineering, Regulatory Affairs, Quality, or related technical field.
• 3+ years of experience in regulatory compliance, product safety, or FDA‑related reporting.
• Familiarity with FDA/CDRH requirements for laser products or similar regulated technologies.
• Strong organizational skills with the ability to manage high‑volume documentation.
• Excellent written and verbal communication skills.
• Ability to work independently and manage deadlines across multiple stakeholders.

 

Preferred

• Experience with CECATS, CDRH Portal, or other FDA submission systems.
• Prior experience in photonics, optics, semiconductor equipment, or medical/laser device industries.
• Working knowledge of environmental compliance requirements such as RoHS, REACH, and WEEE.
• Understanding of product safety and regulatory frameworks related to EMI and EMC.
• Regulatory Affairs Certification (RAC) or similar credential.

 

This role is onsite.

Culture Commitment

Ensure adherence to company’s 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

Coherent is a global leader in lasers, engineered materials and networking components. We are a vertically integrated manufacturing company that develops innovative products for diversified applications in the industrial, optical communications, military, life sciences, semiconductor equipment, and consumer markets. Coherent provides a comprehensive career development platform within an environment that challenges employees to perform at their best, while rewarding excellence and hard-work through a competitive compensation program. It's an exciting opportunity to work for a company that offers stability, longevity and growth. Come Join Us!

Note to recruiters and employment agencies: We will not pay for unsolicited resumes from recruiters and employment agencies unless we have a signed agreement and have required assistance, in writing, for a specific opening.