Regulatory Documentation Engineer (ISO 13485)

Raveone Consultants; Bengaluru; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Appsierra Group in Bengaluru, India seeks a Regulatory Documentation Engineer to manage technical documentation for medical device products, ensuring regulatory compliance and audit readiness.

You will support validation activities, maintain batch records, and drive CAPA investigations with strong writing and cross-functional communication skills.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field.
• 3+ years of documentation and quality control in the medical device industry.
• Strong knowledge of ISO 13485, FDA 21 CFR Part 820 and cGMP.

Responsibilities

• Create, review, and maintain technical documentation, 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 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.

Skills

Documentation

Quality control

ISO 13485

FDA 21 CFR Part 820

cGMP compliance

Education

Bachelor's degree in Mechanical Engineering

Job description

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