Job Description

Job Title: Regulatory Affairs Specialist Location: San Jose, CA Duration: 12+ Months Client: Medical Device Company Job Category: Regulatory Affairs / Compliance Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only) No H1B’s Work hours: 40hr/ week Remote for now but onsite when allowed, must be local 3 Must haves on the resume: ability to multitask working on different project simultaneous, fast learner, ability to prioritize and meet deadlines Description The Regulatory Affairs Specialist will be responsible for the preparation and approval of regulatory submissions required to market new or modified in vitro diagnostic devices (IVD) in international markets or research use only (RUO) products globally. This responsibility entails identifying required documentation, and management of submission to WW RA partners, and working with cross-functional teams to ensure that all data and information required for regulatory submissions and approvals are generated. The position is valid from March 2021 to March 2022. Employment beyond May 2022 will be based on the business need then. Job Responsibilities Negotiate and establish product submission priorities that are aligned with IVDR priorities, and region/country needs. Manage and coordinate the electronic Global Product Submission (eGPS), Regulatory Information Managment (RIM) database to ensure up-to-date, reliable source documents for product registrations are stored, linked, scanned and uploaded into the database. Support product (new & change managment) registrations in assigned regions; monitor and track progress. Respond and track the additional information requests (AIRs/ Tasks) submitted by International Regulatory partners. Conduct surveys to understand regulatory requirements and develop regulatory strategy for products. Provide Monthly registration reports and Quarterly reports as required. Develop and maintain procedures and/or work instructions for product registrations. Coordinate with and collect specific registration information from R&D, Marketing, QA, Medical and other applicable departments as necessary. Interface with OEMs to collect specific registration information. Interface with applicable regulatory agencies and international consulates. Submit and maintain laser registrations for all instruments (IVD and RUO) when needed. Represent RA in core teams as needed. Additional activities as needed to support RA goals. Education Minimum Qualifications: Bachelor's Degree required, preferably in the biological sciences, chemistry or related science. Experience Minimum year’s experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Demonstrated ability to learn and apply learning to projects. Experience with flow cytometry, hematology, and/or immunoassay are a plus. Attention to detail, with emphasis on accuracy and completeness. Effective written and oral communication skills. Good organizational and planning skills; drives for results. Effective analytical/problem solving skills. Good interpersonal skills that involves working well in a team environment and the ability to influence others. Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. Ability to identify areas of concern in moderately complex projects and manage change. Computer literacy (PC, Microsoft Word/Excel/PowerPoint) Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. Working knowledge of project management tools, Microsoft excel and design control preferred Current knowledge of Quality System Regulations (QSR); EU IVDD, Laser product registrations; Machinery Directive and European quality system standards preferred. 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