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Regulatory Affairs

Company: The Judge Group
Location: Palo Alto
Posted on: July 4, 2024

Job Description:

Our client is currently seeking a Regulatory Affairs for a 12 month + contract.Hybrid position, 2 days in office (Palo Alto, CA).Position Description: *Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements* Identifies, analyzes and implements country specific requirements necessary for product related submissions. *Recommend strategies for earliest possible approvals for marketing applications * Performs regulatory projects or acts as a member of the project steering group. * Submits required documentation/information to local authorities or internal. * Initiates and escalates necessary activities if deviations are identified. * Ensures creation of adequate documentation for audits/inspections. * Performs training within the organization in country specific regulatory requirements, if applicable. *Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance. * Performs review of promotional material for regulatory compliance according to country specific requirements.
Impacts: Is expected to adopt existing concepts, methodologies, etc. in order to create and open up new ways of approaching and fulfilling specific internal and external client requests or project requirements.Experience: 5-8 years.Product Registration Experience: --- Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files --- Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files. --- Knowledge of regulatory guidance documents (FDA, Health Canada, EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices). --- Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, ISO 10993-1 as evidenced by coursework or submissions that required use of each standardTeamwork and collaboration: Excellent communication and interpersonal skills to collaborate across departments and interact with design and development teams.Experience with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, PowerPoint, and Adobe Pro.

Keywords: The Judge Group, Palo Alto , Regulatory Affairs, Other , Palo Alto, California

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