All jobs → Partner boards

Quality Assurance / Regulatory Affairs (QA/RA) Specialist

BIOLASE • Corona, CA, US • published 2026-09-26 09:51:26.221650

Description

Job Summary **BIOLASE MG** is seeking an experienced **Quality Assurance / Regulatory Affairs (QA/RA) Specialist** to support medical device quality and regulatory compliance activities, with a strong focus on **EU Medical Device Regulation (EU MDR 2017/745\).** This position will support the Quality Management System (QMS), MDR Technical Documentation, Post\-Market Surveillance (PMS), Periodic Safety Update Reports (PSURs), complaints/vigilance, audits, and product change assessments. The ideal candidate will have hands\-on EU MDR experience and the ability to independently interpret and apply applicable quality and regulatory requirements. **Responsibilities** * Support ongoing compliance with EU MDR 2017/745, including gap assessments, remediation activities, and maintenance of MDR Technical Documentation. * Prepare, review, and maintain applicable EU MDR Technical Documentation, including General Safety and Performance Requirements (GSPRs) and supporting documentation. * Support MDR Technical and Clinical Documentation gap assessments and coordinate required updates with Regulatory Affairs, Clinical, Engineering, Quality, and other process owners. * Support Post\-Market Surveil...

Get jobs like this daily in Telegram: @careeri_bot