Quality Assurance & Regulatory Affairs Specialist

About the Company

Medartis combines innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world's leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

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.
• Assess 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 (e.g., 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.

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 principles.

This is an integral, responsible, and diversified role with a focus on quality and service provision in a rapidly growing, international company.