FDA and Environmental Compliance Reporting Coordinator

in Ipoh Malaysia. 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. Job DescriptionPrepare 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. Key ResponsibilitiesRegulatory Reporting & SubmissionsPrepare 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. ). 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 & RecordkeepingMaintain 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 & CommunicationAct 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 MitigationMonitor 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. 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. PreferredExperience 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 CommitmentIntegrity – Create an Environment of TrustCollaboration – Innovate Through the Sharing of IdeasAccountability – Own the Process and the OutcomeRespect – Recognize the Value in EveryoneEnthusiasm – Find a Sense of Purpose in WorkCoherent 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 UsCoherent 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. About The TeamCoherent Malaysia (formerly known as II-VI Incorporated) began operations in 2001 through the incorporation of Finisar Malaysia with 300 headcounts, now employs over 3000 employees.

Ipoh's assembly and test site for optical components, transceivers, and wavelength management equipment, remains committed to the expansion of Coherent Corporation, accelerated by the growth of next generation products to meet the increasing demands for network bandwidth and data storage.

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! #J-18808-Ljbffr. Compensation: 100 - 134.