EU MDR Quality & Regulatory Specialist

BIOLASE, Inc.; Corona (CA); Hybrid; 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

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.