הרשמה לניוזלטר

Director, Quality Assurance & Regulatory Affairs

דרוש/ה

For a successful Medical Devices company we are looking for Director, Quality Assurance & Regulatory Affairs

עיקרי התפקיד

  • 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 documentation 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 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 products globally is accurate and timely

דרישות התפקיד

  • 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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