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Regulatory Affairs Specialist

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Company :
TechData Service Company LLC

Location :
San Jose, California

Expiry Date :
Fri, 16 Apr 2021 23:59:59 GMT

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Description :
Job Details Full-time | Contract$35 – $40 an hour6 hours ago Benefits – Health insurance – Dental insurance Qualifications – Analysis skills – Flow cytometry – Microsoft Excel – Computer literacy – Communication skills – Bachelor’s degree Full Job Description Job Type: Contract Job Length: 1 Year (Renewable) Compensation: Up to $40/hr W2 Location: Remote but Onsite Once Site Reopens in San Jose, CA Job ID: 37648 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 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 itional 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. itional activities as needed to support RA goals. 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 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. Job Types: Full-time, Contract Pay: $35.00 – $40.00 per hour Benefits: – Dental insurance – Health insurance Schedule: – 8 hour shift – Monday to Friday Experience: – regulatory affairs: 1 year (Preferred) – uality System Regulations: 1 year (Preferred) – Flow cytometry: 1 year (Preferred) Work Location: – One location Work Remotely: – No COVID-19 Precaution(s): – Remote interview process Quick