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Job Field: Legal Jobs
Location: San Jose, CA
Salary: $Not stated

JOB SUMMARY:

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<tr><td valign="top" width="450"><b>The role of the Sr Regulatory Affairs Specialist is to independently plan, coordinate, conduct, and report on BD Biosciences Regulatory Affairs Programs. This includes activities such as preparation of clearance/approval/registration/licensure documentation for regulatory submissions to government agencies (U.S. and worldwide), performing tasks associated with obtaining and maintaining product clearances licenses and registrations, and leading pre-market activities associated with product import/export. This individual will provide input to department projects, identify regulatory activities for project schedules, serve as an RA core team member/extended core team leader, and recommend appropriate actions on regulatory issues. The Sr RA Specialist works on problems of high complexity and diverse scope, in which data analysis requires evaluation of identifiable factors. He/she exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Job Responsibilities: Creates and executes regulatory strategies for US and global registrations and compliance activities of high complexity. Coordinates and prepares, or directs the preparation of complex regulatory submissions, including 510(k) premarket notifications, Premarket Approval Applications (PMA), EU IVDD Technical Files, and documentation required for worldwide registration/licensure of products outside the U.S. Interfaces as needed with European colleagues and Notified Bodies regarding significant changes to products. Provides a high level of regulatory expertise and experience to the unit/segment complex programs, serving as a Core Team member and Extended Team member or leader as assigned. Participates in business interactions and negotiations with regulatory agencies on premarket submission requirements, formats, labeling claims, etc. Organizes and manages (with oversight) meetings with regulators, including development of agendas and training/preparation of company personnel attending the meetings. Monitors FDA and other government agency laws and regulations through websites and publications, and identifies and communicates items needed for interpretation for impact to BDB regulated products. He/she will also provide comments to Sr RA leaders for inclusion in BDX responses to FDA and other agencies Serves an RA team member for promotional materials review, experimental designs, data analysis, and product labeling as they relate to registration and commercialization of medical devices. Reviews product development and clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance. This includes use of appropriate standards, experimental designs, evaluation criteria, and statistical rationale. Participates in functional, data, and design reviews. Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements. Assists in implementing BDB department procedures and maintaining regulatory requirements matrices. Brings Regulatory Affairs questions/issues to the attention of RA management. Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations and policies applying to in vitro diagnostic devices including, 510(k)s, IDEs, PMAs, BLAs, labeling and promotional materials, IVD/ASR/IUO/RUO devices, CLIA/NCCLS/CLSI standards, EU IVDD 968/79/EC, MDD 93/42/EEC, 21 CFR 820, global registration and import regulations, import/export, GCP, GLP, BD Corporate policies/procedures, applied statistics, technical writing. The role of the Sr Regulatory Affairs Specialist is to independently plan, coordinate, conduct, and report on BD Biosciences Regulatory Affairs Programs. This includes activities such as preparation of clearance/approval/registration/licensure documentation for regula

KEY REQUIREMENTS:

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Not stated