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Director, QA & Regulatory Affairs

מס' המשרה: 21307

שם המשרה: Director, QA & Regulatory Affairs

אזור: גוש דן

תיאור של המשרה:
Job Title: Director, Quality Assurance & Regulatory Affairs
Location: IL-Petach Tikva
 

About this opportunity 
The QARA Director is an experienced, hands on professional within the medical device industry with extensive knowledge performing their function within the Food & Drug Administration (FDA) Quality System Regulation (QSR). International Organization of Standardization (ISO) 13485 & 14971. Medical Device Directive (MDD) 93/42/EEC. Canadian Medical Device requirements. Japan’s pharmaceutical Affairs Law (JPAL). and any other applicable worldwide regulatory requirement and business needs (e.g. HIPAA).
The incumbent has the ability to take strategic direction and establish efficient and compliant processes throughout the organization and has strong communication at all levels. This position is to manage the Quality Assurance team members to include incoming inspection, quality assurance, quality compliance, and quality engineering, as well as Regulatory Affairs.
 
In this role, you will… 


Local Management Representative – Understand and perform tasks described within the Quality System for Management Representative duties
Develop, administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
Employ quality assurance methodologies in support of engineering, manufacturing and regulatory functions
Develop and implement quality control and inspection procedures for receipt and control of incoming materials, in-process materials and final product acceptance activities
Define quality control standards and test. specify test equipment and procedures
Establish and maintain test instrument calibration procedures and maintenance schedules
Establish quality assurance and quality control inspection and testing procedures
Identify quality assurance metrics. analyze and report trends to management
Review and host meeting(s) for timely resolution of nonconforming materials
Active participant in all stages of design development, V&V testing and design control activities, ensuring quality assurance considerations and requirements are met
Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical ation where necessary
Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications
Assist in Risk Management activities, FMEAs and ensure compliance to standards and regulations
Assist in the failure investigation of product complaint and CAPA activities
Assist in preparation for and conducting of regulatory agency inspections
Review the Design History File of the iTero system for completeness and adequacy in conjunction with design review activities
Supervise RA activities to ensure that documentation in support of premarket submissions to obtain clearance/approval for the iTero products globally is accurate and timely


In this role, you’ll need … 


Bachelor’s Degree in a technical discipline with a minimum of 10 years’ experience in the medical device industry
Thorough knowledge of FDA (FDA 510(k) experience a plus) Quality System requirements, ISO 13485 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.  Additionally, be familiar with the revised ISO 13485 and new EU Medical Device Regulation. 
Familiar with ISO 62304, Medical Device Software – Software Life Cycle processes
Familiar with the regulatory submission requirements for Class I & II medical devices
Demonstrated success in a start-up, entrepreneurial work environment
Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents
Understanding of software, electrical and mechanical engineering principles
Led the Quality Management System for an entity or location that is MDSAP certified
Led an organization through conversion of an MDD technical file to MDR technical documentation approval by a notified body
Gained global regulatory approvals for at least class 1 and 2 medical devices
Excellent verbal and written communication skills
Effective problem solving skills
Ability to work in a team minded approach to achieve individual and company success
Fluent in computer skills and, at a minimum, the use of Microsoft Office Word, Microsoft Office Excel, Microsoft Office PowerPoint and Microsoft Office Project programs
Demonstrated project management skills and experience
Proficient in timely review of technical and clinical data


 

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