RA/QA Associate @ Employer

RA/QA Associate - Laboratorium - 5 uur geleden geplaatst Do you want to contribute to the quality and safety of innovative medical devices? Do you have a background in Regulatory Affairs or Quality Assurance and enjoy working in a dynamic, international environment? Then we have the right job for you! Your role As an RA/QA Associate , you will play a key role in ensuring the quality and regulatory compliance of medical devices. You will support both Regulatory Affairs and Quality Assurance activities, helping to ensure that our products and processes comply with applicable regulations, quality standards, and internal procedures. In this versatile position, you will be responsible for preparing regulatory documentation, supporting audits, and collaborating with cross-functional teams to maintain the highest quality standards. What will you do? In this role, your responsibilities will include: - Preparing, compiling, reviewing, and maintaining PMA (Premarket Approval) submissions and related regulatory documentation; - Supporting regulatory submissions and conformity assessment activities for high-risk medical devices in the European Union; - Coordinating documentation required for CE marking and reviews by Notified Bodies; - Conducting ISO gap assessments and supporting the implementation of corrective actions; - Assisting in the preparation of pre-approval audits by ensuring documentation, processes, and records are complete and inspection-ready; - Supporting internal and external regulatory audits, including preparation, coordination, and follow-up activities; - Assisting with change notifications to relevant stakeholders; - Contributing to the continuous improvement of the Quality Management System (QMS); - Working closely with cross-functional teams to ensure ongoing compliance with regulatory and quality requirements. What do you bring? You are detail-oriented, quality-driven, and thrive in a structured environment. In addit...