FDA Laser Regulatory Lead – Onsite Compliance & Reporting

Coherent Corp.; Ipoh; On-site; MYR 100,000 - 134,000; Full time

Job summary

Coherent Corp. in Ipoh, Malaysia, is seeking an experienced Regulatory Reporting Specialist to prepare and submit FDA/CDRH reports for laser products and modifications. You will manage accession numbers, ensure proper linkage to product records, and compile annual FDA reports for global product lines.

You will advise engineering teams and compliance units on regulatory needs, provide development guidance, and maintain centralized regulatory records across sites, ensuring audit readiness.

Qualifications

• 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.

Responsibilities

• 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.
• Serve as SME 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.
• Maintain a centralized, audit-ready repository of all FDA submissions, correspondence, certifications, and regulatory records.
• Ensure consistent documentation practices across all global Coherent sites.
• Act as official correspondent with FDA/CDRH for inquiries, submissions, and follow-up actions.
• Respond promptly to FDA requests, including urgent inquiries related to product releases or export certifications.
• Monitor regulatory changes and ensure processes align with FDA expectations.
• Identify compliance risks and recommend corrective actions or process improvements.
• Support internal audits, external inspections, and compliance reviews.

Education

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

Regulatory Affairs Certification (RAC)

Tools

esubmitter

ESG Next Gen gateway

Job description

Coherent Corp. in Ipoh, Malaysia, is seeking an experienced Regulatory Reporting Specialist to prepare and submit FDA/CDRH reports for laser products and modifications. You will manage accession numbers, ensure proper linkage to product records, and compile annual FDA reports for global product lines.

You will advise engineering teams and compliance units on regulatory needs, provide development guidance, and maintain centralized regulatory records across sites, ensuring audit readiness.