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Job #03630

About our client Our client is a mid-size pharmaceutical company with a robust pipeline and a number of products in late-stage clinical trials. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Manager/Director California Salary Highly competitive package, commensurate with experience Responsibilities 1) Work as part of the Regulatory Affairs department with direct responsibility for the preparation of documentation for international and domestic product registrations, permits and licenses 2) Assist in the evaluation of change control documents, including advertising, promotional materials, package inserts, box labels and training materials, etc. 3) Participate on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, corrective/preventive action, etc.) 4) Interface with state, federal, international regulatory agencies as well as international distributors regarding registrations and licenses 5) Participate on product project teams with responsibility for determination of regulatory submission needs, proposal of regulatory strategy and preparation of documentation for international and domestic new product registrations permits and licenses 6) Ensure compliance to all relevant regulatory requirements and standards corrective/preventive action, MDR/MDV, etc.) 7) Participate on internal/external project teams involving regulatory review, approval and feedback (e.g. complaint handling, design controls, 8) Generate/revise documentation and data necessary for department operations (e.g. SOPs, forms, tables, records, reports, meeting summaries, etc.) 9) Ensure product technical files, documentation and relevant clinical/scientific literature are maintained and periodically updated as required 10) Evaluate change control documents, including advertising and promotional materials, package inserts, box labels, training materials, etc 11) Handle additional projects as required 12) Travel to company affiliates, industry conferences/meetings or external training events may occur as required Requirements 1) BS/BA in any biological science (or equivalent combination education and/or work experience) with 3+ years of regulatory experience in a medical device or IVD manufacturing environment 2) IVD experience especially in the cardiovascular or home-testing markets, and/or CLIA waiver expertise 3) Strong knowledge of quality systems in a manufacturing environment 4) Working knowledge of current and evolving state, federal, international regulations and procedures relevant to the approval of IVDs and medical devices 5) Ability to work cohesively with multi-disciplinary scientific working groups and regulatory agencies