Regulatory Documentation Engineer (ISO 13485)

Regulatory Documentation Engineer

We are seeking a detail-oriented Regulatory Documentation Engineer to manage and maintain quality and technical documentation for our medical device products. In this role, you will ensure our documentation practices meet regulatory requirements, support validation activities, and help maintain audit readiness across the organization.

Key Responsibilities

• Create, review, and maintain technical documentation, Standard Operating Procedures (SOPs), and Work Instructions for medical device components and processes
• Support validation activities (IQ/OQ/PQ) and prepare corresponding validation reports
• Maintain batch manufacturing records and batch packaging records to ensure readiness for regulatory inspections
• Document engineering changes and support Corrective and Preventive Action (CAPA) investigations
• Ensure all logs and documentation adhere to ALCOA+ data integrity principles
• Promote ongoing regulatory compliance across the organization through regular training and process reinforcement.

Qualifications & Requirements

• Bachelor's degree in Mechanical Engineering or a related field
• 3+ years of experience in documentation and quality control within the medical device industry
• Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and cGMP requirements
• Excellent problem-solving and analytical skills
• Exceptional attention to detail, with strong technical writing and cross-functional communication skills