Onsite FDA Regulatory Reporting Specialist

Coherent; Chemor; On-site; MYR 90,000 - 130,000; Full time

Benefits offered by this job

Onsite

Job summary

Coherent Corp. is seeking a Regulatory Reporting Specialist to manage FDA submissions for laser products and product changes. You will oversee accession numbers and ensure accurate linkage to product records while compiling annual FDA reports for global products.

The role requires a strong regulatory background, experience with FDA/CDRH rules, and excellent organizational and communication skills to coordinate with product engineering, trade compliance, and business units.

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.

Skills

Regulatory knowledge

Documentation management

Communication

Education

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

Tools

eSubmitter

ESG Next Gen gateway

Job description

Coherent Corp. is seeking a Regulatory Reporting Specialist to manage FDA submissions for laser products and product changes. You will oversee accession numbers and ensure accurate linkage to product records while compiling annual FDA reports for global products.

The role requires a strong regulatory background, experience with FDA/CDRH rules, and excellent organizational and communication skills to coordinate with product engineering, trade compliance, and business units.