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 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

Bachelors 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

Required Skills:

ISO 13485 Regulatory Affairs Technical Writing Quality Management Systems Auditing CAPA Project Management Risk Management FDA Submission