Sr. Director/VP Of RA/QA

* Be responsible for submissions to regulatory agencies which get products rapidly approved or cleared to markets in the US and abroad, including the preparation of IRB, IDE, 510(k)/and or PMA and CE Mark applications as required.
* Review and approve product marketing strategies and practices with regard to compliance to clearances and approvals received in national markets
* Develop department of RA professionals and the in-house regulatory competencies, managing a team of direct reports including a Director of Regulatory Affairs.
* Company Officer and member of Executive Team; primary liaison with Company Board of Directors on all Regulatory Affairs matters.
* Implement and maintain programs and processes to ensure high quality products and compliance with the QSR and ISO 13485
* Establish and maintain a company-wide QSR/ISO 13485 training program
* Act as primary liaison and direct interactions with FDA, State Department of Health and notified bodies during company inspections
* Manage internal audit program; act as Lead Auditor
* Develop and maintain facilities, equipment, and procedures for testing and analyzing incoming materials
* Oversee final release activities for all manufactured commercial products and clinical materials, including review of manufacturing, environmental monitoring, and quality control data
* Participate on Change Control Board; approve all new and revised production-related documents
* Develop and administer department budgets, objectives, schedules, training plans and performance reviews

Requirements:
* Extensive knowledge of Quality Systems including QSR, MDD, and ISO 13485:2003
* B.S. in life sciences, engineering, or equivalent required; MS preferred
* 10+ years related experience in the medical device industry
* Have a minimum of 5 years in a Regulatory Affairs management role

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