Device QA DIRECTOR

Primary purpose and function of this position: 
 General Duties & Responsibilities: 
·        Lead & Support regulatory and quality aspects of device and drug/device combination elements through the product life cycle .  
·        Build Regulatory strategy for development and submission along the project 
·        Review device related protocols/reports to ensure compliance with the regulatory demands (for example: review risk analysis file, ensure that it gives answer to FDA expectations, review usability specification – ensure that it follows the standard guidelines, etc.) 
·        Lead all product compliance activity: Applicable standards, directives and guidance   
·        Point of contact for the authorities – responsible to initiate the plan and the discussion in front of the authorities  
 Education & Experience 
·        Bachelor’s degree or higher in a scientific or mechanical engineering discipline
·        at least 5 years related experience in a direct quality and regulatory role in a drug delivery products , preferably infusion pumps .
·        Extensive knowledge of applicable regulations including EU and US. ability to effectively communicate with and positively influence people. 
 Knowledge, Skills & Abilities:  
·        Working knowledge of QSR’s, ISO 13485, MDD/MDR, MDSAP, and FDA requirements and standards. 
·        Strong interpersonal, communication, analytical and complex problem solving skills. 
·        The ability to develop partnerships and influence. 
·        Ability to work independently and has strong team building skills. 
·        An understanding of the principles of configuration management and document control.
Reports To: VP QA