Quality Assurance & Regulatory Affairs Specialist

Your responsibilities

Manage the post market surveillance system.

Ensure all PMS documentation and records are properly completed and  maintained in the designated document control system per applicable company procedures.

Initiate, coordinate and process customer complaints per applicable company procedures including communicating with customers regarding complaint information.

Asses risk and reportability of customer complaints per applicable regulatory requirements.

Ensure complaints are investigated, closed and documented per applicable company procedures.

Complete and submit documentation to regulatory authorities, in the required timeframe, for reportable events per applicable regulatory requirements, ex. FDA MDRs

Initiate, coordinate and process health hazard evaluations (HHE’s) per applicable company procedures.

Ensure HHE’s are investigated, closed and documented per applicable company procedures.

Initiate, coordinate and process field actions per applicable company procedures.

Ensure field actions are closed and documented per applicable company procedures.

Gather, maintain and provide PMS data and metrics, as required, for Quality Management System (QMS) monitoring.

Participate in QMS processes including but not limited to, audits, corrective and preventative action (CAPA) investigations, and document control.

Prepare and update Quality documents such as SOPs, Work Instructions and Forms.

Follow FDA Quality Systems Regulation, ISO Standards and Standard Operating Procedures as established by Medartis policies, practices and procedures.

Maintain effective working relations, communications and feedback with all other departments and external partners.

Ensure that all record keeping, and documentation is completed in a timely manner according to established policies, practices and procedures.

Your qualifications

Good understanding of ISO 13485:2016

Good understanding of CFR Part 803 Medical Device Reporting

Good understanding of CFR Part 806 Medical Devices; Reports of Corrections and Removals

Previous experience in a regulated industry is preferred.

Proficient in the use of Microsoft Word, PowerPoint and Excel.

Knowledge of basic engineering principals.