FDA Laser Compliance Coordinator & Regulatory Reporting

Coherent; Ipoh; On-site; MYR 65,000 - 90,000; Full time

Job summary

Coherent Corp. is seeking an FDA and Environmental Compliance Reporting Coordinator to manage regulatory submissions for laser products, maintain linked product records, and prepare annual worldwide FDA reports.

The role requires collaboration with engineering, Trade Compliance, and business units to ensure readiness and accuracy in all regulatory communications. The ideal candidate will have a degree in Engineering or Regulatory fields, 3+ years of FDA-related experience, and familiarity with

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.

Responsibilities

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

Skills

Regulatory compliance

FDA reporting

Documentation management

Stakeholder coordination

Written communication

Education

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

Tools

CDRH portals

FDA submission systems (e.g., esubmitter)

Job description

Coherent Corp. is seeking an FDA and Environmental Compliance Reporting Coordinator to manage regulatory submissions for laser products, maintain linked product records, and prepare annual worldwide FDA reports.

The role requires collaboration with engineering, Trade Compliance, and business units to ensure readiness and accuracy in all regulatory communications. The ideal candidate will have a degree in Engineering or Regulatory fields, 3+ years of FDA-related experience, and familiarity with