FDA and Environmental Compliance Reporting Coordinator

Coherent Corp.; Ipoh; On-site; MYR 70,000 - 110,000; Full time

Job summary

Coherent Corp. in Malaysia seeks a Regulatory Reporting specialist to lead FDA/CDRH submissions for laser products, maintain accession numbers, and compile annual FDA reports across global sites.

You will advise engineering teams on regulatory requirements, ensure audit-ready documentation, and serve as the official FDA liaison, coordinating with esubmitter and ESG gateways to meet deadlines and compliance expectations.

Qualifications

• 3+ years of experience in regulatory compliance, product safety, or FDA‑related reporting.
• Strong organizational and documentation skills.
• Excellent written and verbal communication abilities.

Responsibilities

• Prepare and submit FDA/CDRH reports for new laser products, product modifications, and manufacturing location changes.
• Manage and maintain accession numbers and ensure linkage to product records.
• Compile, validate, and submit the annual FDA report covering all applicable Coherent products worldwide.

Skills

Regulatory compliance

FDA reporting

Documentation management

Education

Bachelor’s degree in Engineering, Regulatory Affairs, Quality, or related field

Tools

FDA submission systems

esubmitter

ESG Next Gen gateway

Job description

Job Description

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!

About The Team

Coherent 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!