QA / RA Specialist

Job Summary

BIOLASE MGis seeking an experiencedQuality Assurance / Regulatory Affairs (QA/RA) Specialist to support medical device quality and regulatory compliance activities, with a strong focus onEU 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 supportingNotified Body audits and EU MDR Technical Documentation assessments.
• Experience withEU MDR transition, certification, remediation, or gap-assessment activities.
• Experience preparing or maintainingGSPRs and responding to Notified Body questions or findings.
• Experience supportingMDSAP 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!