QA / RA Specialist

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.

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!

BIOLASE MG, LLC is an Equal Opportunity Employer. We are committed to providing equal employment opportunities to all applicants and employees and prohibit discrimination based on race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.