About this role
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
- Bachelors 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!