About The Role

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.

I ntegrity – Create an Environment of Trust

C ollaboration – Innovate Through the Sharing of Ideas

A ccountability – Own the Process and the Outcome

R espect – Recognize the Value in Everyone

E nthusiasm – Find a Sense of Purpose in Work

Coherent Corp. is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.