QA​/RA Specialist

# QA / RA Specialist Hot Job Corona, CA 92880## Overview Salary Range $7, - $9, Salary/year Position Type Full Time## 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 Surveillance (PMS) activities, including collection, analysis, safety, quality, and product performance data.
* Prepare and maintain applicable Periodic Safety Update Reports (PSURs) in collaboration with Regulatory Affairs and other functional stakeholders.
* Support complaint investigations, documentation, trending, and vigilance/reportability evaluations, coordinating with Regulatory Affairs when regulatory assessment or Authority reporting is required.
* Prepare for and participate in Notified Body assessments, internal/external audits, MDSAP audits, FDA inspections, and ISO certification audits, including responses to findings and remediation activities.
* Support and maintain the Quality Management System (QMS) in accordance with ISO 13485, EU MDR, applicable FDA requirements, and MDSAP.
* Review and update SOPs, work instructions, forms, and other QMS documentation to maintain quality and regulatory compliance.
* Work cross-functionally with Quality Assurance, and Regulatory Affairs
* Perform other related Quality and Regulatory compliance activities and projects as assigned.## Qualifications
** Education and/or Experience
*** Bachelor’s degree in a relevant field and/or equivalent relevant experience.
* Minimum 3 years of Quality Assurance and/or Regulatory Affairs experience within the medical device industry.
** Preferred Qualifications
*** Experience supporting
** Notified Body audits and EU MDR Technical Documentation assessments**.
* Experience with
** EU MDR transition, certification, remediation, or gap-assessment activities**.
* Experience preparing or maintaining
** GSPRs
* * and responding to Notified Body questions or findings.
* Experience supporting
** MDSAP and/or FDA inspections**.
* CQA, CQE, RAC, ISO 13485 auditor training, or similar certification is a plus.

Join us to be part of a passionate team committed to delivering safe, high-quality products through rigorous quality assurance practices and regulatory compliance!