Quality and Regulatory Affairs Manager

Details: Quality and Regulatory Affairs Manager Direct Hire The Quality and Regulatory Affairs Manager is responsible for maintaining our quality and regulatory compliance with US FDA, Europe, Canadian, and all other national or international regulatory agencies. This position’s main responsibilities focus around the research, understanding, and communication of quality and regulatory standards throughout the organization to ensure products and processes comply with all required standards. Among other responsibilities, this role is responsible for the preparation and submission of documentation to suppler compliance market entry at local, state, federal and international levels. This role is also responsible for managing the international product registration process in concert with his / her colleagues at other international sites to author formal communications with regulatory agencies, submit MDRs or adverse event reports and manage any required recall activities. Additionally, this role is responsible for ensuring compliance of the company’s quality system to the requirements of the FDA’s CFR 21 Quality System Regulations (QSR), ISO9001, ISO13485, Health Canada Medical Device Directive (SOR-98-282), and the European Medical Device Directive (Council Directive 93/42/EEC). Responsibilities: Work with CEO and other Senior Management Staff members to device and set quality and regulatory strategies to ensure rapid and timely approval of devices. Interpret existing or new regulatory requirements as they relate to the company products and procedures, clinical studies, testing or records keeping Provide quality and regulatory support to various organizations / teams including regulatory filing strategies, testing and standards requirements and support filing process Review, analyze and approve technical data generated by R&D, Manufacturing, Marketing, Quality Assurance or other related departments Review, provide feedback and approve design and manufacturing changes, non-conforming materials reports, rework orders, test protocols, and test summary reports to ensure regulatory compliance with FDA and applicable standards, and determine filing requirements Review promotional and advertising materials, complaints, and lead vigilance and MDR reporting efforts Prepare US and International regulatory submissions, including, but not limited to 510(k), PMAs, Supplements, Technical Files, Design Dossiers, and Change Notices Review and advise on labeling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations Advise on international product registration and export approval requirements Act as a direct liaison with regulatory authorities Serves as primary company contact with all regulatory agencies Focal and primary contact on all audits Registers the facilities and products manufactured for domestic and international distribution Responsible for proper handling of all product safety related complaints and any required regulatory notifications Conducts GMP, Health Canada, European Medical Device Directive, ISO13485 and ISO9001 training as required Monitors standards, regulations, and laws and alerts management and customers to proposed or pending changes which may impact the company’s operations Obtain and maintain various regulatory permits Respond to requests from regulatory authorities Conduct conference calls, meetings, and presentations with FDA reviewers and inspectors as needed Develop regulatory processes and procedures as needed Qualifications: The Director of Quality and Regulatory Affairs must have excellent problem solving and presentation skills, as well as the ability to learn a new environment quickly. The incumbent must have the experience and credibility to communicate and influence change at all levels within the organization. This role will identify, communicate and implement the key priorities to the organization with little guidance or direction and exercising judgment to determine sense of urgency for priority. This role will promote cross-functional problem solving and cooperation. Educational Requirements / Experience: Bachelor’s Degree in a scientific discipline A minimum of 10 years of experience in Regulatory Affairs in a regulated IVD industry Experience in Quality Control setting with FDA regulations and/or ISO standards (FDA’s CFR 21, ISO 9001, ISO 13485) the European Medical Device Directive (93/42/EEC), and the Health Canada Medical Device preferred Strong background with 510k submissions Proven strong leadership/managerial skills Proven ability to manage multiple projects in a matrix team environment. Masters in Regulatory Affairs a plus. Experience in directly interacting with Regulatory Agencies and Trade Associations Excellent analytical, interpersonal, vourl and written communication skills Demonstrated experience with the successful use and implementation of Six Sigma tools / methodologies Team player with strong customer orientation and ability to work in multinational and multicultural environment Frequent interaction with domestic and international government agencies Why Kelly ® ? With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 97 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year. You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today. About Kelly Services ® Kelly Services, Inc. (Nasdaq: KELYA, KELYB) is a global leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the world, Kelly provided employment to more than 555,000 employees in 2014. Revenue in 2014 was $5.6 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Download WorkWire ™ , a free career and employment resource iPad® app by Kelly Services. iPad is a trademark of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce.
See Job Full Description
Biotech Jobs from Latest CareerBuilder Jobs: Biotech, US - 30 mile radius http://ift.tt/1dvBWAz