QA / RA Specialist

BIOLASE, Inc.; Corona (CA); On-site; USD 7,500,000 - 9,000,000; Full time

Job summary

BIOLASE MG in Corona, CA is seeking a QA/RA Specialist to support medical device quality and regulatory compliance, with a strong emphasis on EU MDR 2017/745. This role supports the QMS, MDR Technical Documentation, PMS, PSURs, complaints, audits, and change assessments.

The candidate should have hands-on EU MDR experience and the ability to coordinate with Regulatory Affairs, Clinical, Engineering, and Quality, including Notified Body inquiries and inspections.

Qualifications

• Bachelor’s degree in a relevant field and at least 3 years of QA/RA experience in medical devices.
• Experience supporting Notified Body audits and EU MDR Technical Documentation assessments.
• Experience with EU MDR transition, certification, remediation, or gap assessment activities.

Responsibilities

• Support EU MDR 2017/745 compliance, including gap assessments and maintenance of MDR Technical Documentation.
• Prepare, review, and maintain EU MDR Technical Documentation and GSPRs.
• Support PMS activities, PSURs, and safety data analysis.
• Coordinate complaint investigations and regulatory reporting with Regulatory Affairs as needed.
• Assist with Notified Body assessments, internal/external audits, and remediation of findings.
• Maintain and update QMS documentation per ISO 13485 and EU MDR requirements.

Skills

Quality Assurance

Regulatory Affairs

EU MDR

Notified Body Audits

Education

Bachelor's degree

Job description

# QA / RA SpecialistHot JobCorona, CA 92880## OverviewSalary Range$7,500,000.00 - $9,000,000.00 Salary/yearPosition TypeFull 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!