RAQA Technical Writer

Overview

Our global medical device company is seeking a RAQA Technical Writer to support quality and regulatory compliance across the product lifecycle. This individual will play a key role in developing and maintaining critical documentation, ensuring adherence to regulatory standards, and supporting audit readiness.

This is an individual contributor role requiring strong attention to detail, sound judgment, and the ability to work independently in a regulated environment.

Key Responsibilities

• Develop, review, and maintain quality and regulatory documentation, including:
  • Standard Operating Procedures (SOPs)
  • Work instructions
  • Validation protocols and reports
  • Regulatory submission documentation
• Ensure compliance with applicable standards and regulations (e.g., FDA, ISO 13485, GMP)
• Support quality assurance activities across:
  • Laboratory studies
  • Clinical research
  • Manufacturing and production processes
  • Raw materials and finished products
• Assess potential risks and provide compliance recommendations
• Facilitate and support internal and external audits and regulatory inspections
• Coordinate and contribute to quality and compliance training initiatives
• Partner cross-functionally with teams in Quality, Regulatory, R&D, and Operations

Qualifications

• Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, or similar) or equivalent practical experience
• Strong understanding of quality systems and regulatory requirements in a regulated industry
• Experience with technical writing in a quality or regulatory environment preferred
• Familiarity with FDA regulations, ISO standards, or similar frameworks is a plus
• Strong organizational skills and attention to detail
• Ability to work independently and manage multiple priorities
• Excellent written and verbal communication skills

Additional Details

• Opportunity to support a global, highly regulated medical device environment
• Exposure to end-to-end product lifecycle and cross-functional teams