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Regulatory Affairs

Company: Marquee Staffing
Location: Irvine
Posted on: March 27, 2020

Job Description:

Position Regulatory Affairs Location Irvine, CA Duration 12 Months Contract Regulatory Affairs You would be responsible for developing and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory approval for the organization s products. Work with the VP of QARA and other members of the QARA team to set strategy for worldwide governmental approval to introduce new products to market, provide advice on regulatory requirements and prepare worldwide submissions. ESSENTIAL FUNCTIONS AND BASIC DUTIES Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory strategies with leadership team, as necessary, and negotiate submission steps with regulatory bodies. Work with the VP of QARA and other members of the QARA team to prepare regulatory strategiesplans and worldwide requirements lists. Provide on-going support to core and project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations. Provide business and product information to Sr. Director of Quality and Regulatory Affairs to enable development or strategies and requirements, and communicate information to leadership team. Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required. Work with the VP of QARA and other members of the QARA team to negotiate directly with the FDA or other international agencies, as needed. All significant changes will be reviewed with the Sr. Director Quality and Regulatory Affairs. Participate in the development of general strategies, including how to interact more effectively with government agencies and agency personnel. Maintain Regulatory Affairs product files to support compliance with regulatory requirements. Interact frequently with different members of the organization and outside customers. Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas. Review training, promotional and advertising pieces for assigned product lines. Provide training and support to other members of the department. Manage Establishment Registrations, FDB Licensing, etc. Support Quality Systems Projects as required. QUALIFICATIONS EducationCertification Bachelor s Degree, preferably in Science or Engineering field. Required Knowledge Ability to provide solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practical and consistent with organizational objectives Strong problem solving skills. Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions Strong organizational, time management and project management skills Strong knowledge of Microsoft Office Demonstrated proficiency with global regulatory planning and strategy for submission preparation (including but not limited to 510(k), IDE, supplements and amendments, Technical Files and Design Dossiers) Clinical, Quality or Regulatory compliance experience Significant regulatory knowledge in a number of areas. Experience with premarket and postmarket product line support Strong understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines Demonstrated ability to independently assess risk and develop solutions to critical and difficult problems that are consistent with organizational objectives Experience Minimum of 2-3 years of experience required SkillsAbilities Effective presentation and interpersonal skills Self- motivation Excellent verbalwritten communication skills. Project Management and Problem Solving Skills Strong attention to detail and accuracy. Ability to communicate persuasively in a manner that supports approvals and other key company goalsobjectivesPandoLogic. Keywords: Compliance Director, Location: Irvine, CA - 92604

Keywords: Marquee Staffing, Irvine , Regulatory Affairs, Other , Irvine, California

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