IEC Compliance Engineer

Welcome to Arthrex we are a global medical device company and leader in new product development and medical education in orthopaedics. With a corporate mission of helping surgeons treat their patients better, Arthrex has pioneered the field of arthroscopy and developed more than 7,500 innovative products and surgical procedures to advance minimally invasive orthopaedics worldwide.

In support of product development, develop and manage the regulatory strategy, develop deliverables in compliance with relevant design control procedures, obtain certifications in compliance with relevant governing standards, and support regulatory submissions for compliance with worldwide submissions.

• Develops strategies for worldwide governmental approvals/clearances to introduce new and modified products to the market and advises on regulatory requirements.
• Contributes to system evolutions and migrations as necessary to ensure seamless transition and improvements as planned.
• Develops and manages engineering documentation in support of new product development in compliance with relevant policies and standards.
• DHF
• Technical File
• IFU/DFU
• Risk Management File
• Usability Engineering File
• Labeling
• Develops and manages product compliance to relevant standards governing medical electrical equipment.
• Contributes to efficient and effective project management.
• Supports document control to ensure compliance with QMS and in support of system evolutions as necessary.
• Supports execution of engineering changes, lifecycle changes, and document changes prior to release.
• Create mechanisms for understanding impact: material dispositions, manufacturing process, regulatory, quality.
• Supports new product 510 (k) notifications, CE Mark Technical Files/Dossiers, and international product registrations.
• Supports Quality System Audits conducted by FDA, Notified Body and other Regulatory Agency Audits.

• Bachelor’s degree required preferably in a Science or Engineering discipline.
• 3 years direct experience in a Medical Device Company required.
• Regulatory experience in U.S. required, Europe (CE) and Canada highly desirable.
• Knowledge of FDA Quality System Requirements,
• ISO 13485 and CMDR Quality System Requirements,
• ISO 14971 Risk Management Requirements,
• IEC 62304 Medical device software – Software life cycle processes
• IEC 60601 Safety and Effectiveness of medical electrical equipment
• IEC 62366 Application of usability engineering
• MDD Medical Device Directive
• GMP, Good Manufacturing Practices.
• RAC Certification a plus.
• Training in technical aspects of medical electrical equipment and medical device development.
• High degree of understanding of regulatory requirements - how they operate, how to obtain updated information and where to obtain interpretations of them.