QA & RA Officer

QA & RA Specialist
A growing MedTech company is looking to strengthen its Quality & Regulatory Affairs team to support the expansion of its product portfolio across international markets. The QA/RA Specialist will help maintain the company’s Quality Management System and support regulatory activities to ensure continued compliance with global standards and regulations.

Key Responsibilities

• Maintain and support the ISO 13485-compliant Quality Management System, ensuring ongoing regulatory compliance

• Support regulatory submissions and international product registrations across multiple markets

• Manage quality processes including complaints, non-conformities, and CAPA activities

• Support and coordinate internal and external audits and management review activities

• Contribute to the preparation and maintenance of technical documentation and regulatory strategies

Your Profile

• Bachelor’s degree in science, engineering or a related field

• 3+ years of experience in QA/RA within MedTech or another regulated industry

• Experience working within an ISO 13485 Quality Management System

• Knowledge of regulatory submissions or product registrations (MDR, FDA or similar frameworks)

• Strong communication skills in English