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 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.
About Us
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.
