Quality & Regulatory Affairs Director
Location:
Parsippany, NJ
Description:
This position is responsible for: - Oversight of all facets of regulatory and quality support for reconstructive development division. - Oversight of the development of regulatory submissions; departmental projects; development of or creation and review of labeling; provision of guidance and consultation for domestic and international regulations; interaction with governmental agencies, ensuring compliance with quality system requirements - Oversight/management of a staff of quality and regulatory professionals. - Providing Regulatory and Quality guidance to the company, including executive management and the Legal department, and staying aware of current developments and potential changes and opportunities in U.S. and other regulatory jurisdictions. - Oversight and development of international and domestic regulatory submissions, including 510(k), IDE, and PMA submissions. Oversee pre-submission meetings with FDA and notified bodies, review of proposed labeling to ensure intended use and claims are supported for use, and review product process changes to ensure compliance to domestic and international regulations, as wellas impact to domestic and international submissions Principal Duties and Responsibilities: · Interface with regulatory bodies such as FDA, and notified body during routine audits · Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization. Keeps all areas informed of regulatory requirements and emerging issues which may affect the registration approval of products · Manage the assigned Quality functions in support of customer satisfaction through the timely, efficient support of product development activities, including design reviews, verification, validation, and transfer. · Develops departmental strategy and manages departmental function to achieve key objectives; is alert to the potential to use new technology to achievegreater efficiencies. · Manages and develops personnel to lead them to higher performance levels and maximize their career potential. · Establishes QA/RA policy and procedures and ensures compliance with them. Expected Areas of Competence: · Medical device quality assurance and quality systems experience is required. · Proficient in FDA medical device regulations with an understanding of the global regulatory environment. · Manufacturing, and product development experience as well as orthopedic knowledge is desirable. · Ability to foster individual and group development by identifying and arranging appropriate assignments, formal training or other experiences. Develops emerging talent to assume new or increased responsibilities in the future. · Ability to develop and champion an organizational culture that promotes behaviors that lead to superior business performance. · Exhibits good business sense, capable of identifying business needs and opportunities relative to products and services. · Acts in a balanced and ethical manner when dealing in gray areas of regulation. · Demonstrated ability to learn key orthopedic product and process knowledge quickly. · Strong written and verbal communication and interpersonal skills. Education/ Experience Requirements: · Bachelor's degree in relevant field (e.g., engineering, materials science orlife science) is required, and Master's degree is preferred. · ten to fifteen years of experience in Quality and Regulatory. Extensive experiencein medical device operations which enables 1st-hand knowledge ofmanufacturing, QC/QA and interface with R&D. · Proven success in a leadership role. · CQE/CQA Preferred.Listing originally posted at http://www.bullhornreach.com/job/517319_quality-regulatory-affairs-director-parsippany-nj?utm_source=oodle.com&utm_medium=referral&utm_content=job&utm_campaign=feeds1
Phone:
(866) 203-8227
Posted:
October 2 2012 on Oodle
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More About this Listing: Quality & Regulatory Affairs Director
Quality & Regulatory Affairs Director is a Executive Director Job located in Parsippany NJ. Find other listings like Quality & Regulatory Affairs Director by searching Oodle for Executive Director Jobs.
Quality & Regulatory Affairs Director is a Executive Director Job located in Parsippany NJ. Find other listings like Quality & Regulatory Affairs Director by searching Oodle for Executive Director Jobs.