Shire Jobs

Becton, Dickinson and Company seeks a Senior Regulatory Affairs Specialist to coordinate, prepare, and follow up with OUS submissions in a timely manner. Act as liaison with regions and Business group to acquire required documentation for submission. Work with OUS to support registrations/amendments due to proposed device changes. Prepare/support regional submissions with appropriate input/help from various functions (R&D, Quality, Manufacturing, etc.). Represent RA in product life cycle development teams by reviewing, approving, and providing input to project teams as to the impact of regional registrations. Coordinate and collect specific registration information with R&D, Manufacturing, QA, Medical and other applicable departments. Represent RA in design teams and projects by providing regulatory guidance during the product development cycle and coordinating team inputs for OUS submissions. Support International Registrations as it relates to product changes and/or new product launches. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. Coordinate and respond to requests for product data/information, surveys/questionnaires requested by customers. Hybrid in-office/remote position.Position requires a Master’s degree in Regulatory Affairs and two (2) years of work experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Regulatory Affairs and two (2) year of work experience in the job offered or related occupation in which the required experience was gained, employer will also accept a Bachelor's degree in Regulatory Affairs and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Applicants must also have demonstrated experience in the following: Medical device regulations; International product registrations; 21 CFR 820 - Quality System Regulations; FDA guidelines; Inventory management systems; Review, collate and summarize scientific, clinical and technical data; Handle master documents, drawings, and specifications; and Detail-oriented, methodical and able to handle regulatory information and submissions.To apply, mail resume to: Becton, Dickinson and Company, Attn: BDHR - CS, 3750 Torrey View Ct., San Diego, CA 92130, or submit a resume to https://www.nj.gov/labor/career-services/, or submit a resume to https://bdx.wd1.myworkdayjobs.com/EXTERNALCAREERSITE_USA. Must Reference Job Title: Senior Regulatory Affairs Specialist. Code: R-492700. EOE.