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Senior Regulatory Affairs Analyst - Onsite - W2

Company: Softpath System, LLC.
Location: West Sacramento
Posted on: June 7, 2020

Job Description:

Title Senior Regulatory Affairs Analyst - Onsite Location West Sacramento, CA 95691 Duration 6+ Months Description Interprets federalstateinternational regulations as they apply to our products, processes andor procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Performs regulatory affairs functional responsibilities in support of new product development and commercialization. Represent Regulatory Affairs for PD- (CT) for Japan project. Includes delivery of three panels (1 combo and 2 MICs) including new antibiotic CT and updated breakpoints for three other antibiotics. PD-NIID Custom Panel with Software development. (Average RA resource Demand through launch 0.25). Support QE deliverables as available for PD-CT. Draft PD-8 Regulatory Plan and panel layout approvals. Layout approvals by 73120 for project acceleration. (10-12 panels). Support PD-8 deliverables as available. (Average RA resource Demand through launch 0.30). Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance andor approval and appropriate country licenses and certificates for new products andor changes to existing products. Will establish and maintain compliance to applicable regulatory requirements will prepare and manage registration, submissions and technical documentation. Will work closely with QRA team and all site functions to support business. Required EducationExperience Bachelorrsquos degree in field with 5+ years exp. OR Masterrsquos degree in field with 3+ years of experience working with regulatory requirements and agencies specifically FDA, IVDD and ISO 13485 required. No supervisory responsibilities but provides informal guidance to product team members. Explains complex information to others in straightforward situations. Desired Skills Abilities In-depth knowledge of MicroScan product development and RA experience highly preferred. Experience with the IVDD product requirements and 510(k) clearance process preferred. Microbiological Auto IDAST products, hardware software. Experience with good manufacturing practices (GMP). Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971 and other applicable standards and regulations. Possess a working knowledge of surrounding areas including Regulatory Compliance Development. Experience with pre-market regulatory activities (new product development) is strongly preferred. Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles) If interested please email me at Adnansoftpath.net and or call me (Adnan) at 678-783-7457678-888-4942.

Keywords: Softpath System, LLC., West Sacramento , Senior Regulatory Affairs Analyst - Onsite - W2, Professions , West Sacramento, California

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