Rapid Medical is a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are seeking a talented QA/RA Engineer to join our quality and regulatory team, playing a dual role that ensures our products meet the highest quality standards while navigating complex global regulatory requirements.
SCOPE & RESPONSIBILITIES Quality Assurance • Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. • Manage DCOs in the PLM system: write and update QA procedures to ensure compliance with quality standards and regulatory requirements. • Manage NCR and CAPA processes: lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. • Manage QA production activities: provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. • Ensure timely resolution of quality issues: promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. • Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EU MDR, and MDSAP requirements. • Supplier Quality Management: manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.
Regulatory Affairs • Prepare, coordinate, track, and follow up on submissions for medical devices across various international markets. • Prepare and manage EU MDR technical documentation submissions. • Oversee CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall. • Participate in regulatory inspections and audits. • Prepare regulatory assessments for design changes. • Develop labeling according to applicable regulatory requirements. • Evaluate and communicate regulatory impact of ECOs and design changes across QA and RA domains.