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Regulatory Affairs Specialist III

Spectraforce Technologies
United States, California, Irvine
Jul 30, 2025
Title: Regulatory Affairs Specialist III Duration: 17 Months Location: Irvine, CA 92603 (This role will start on-site and transition to a hybrid setup later. ) Description: Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval. Demonstrates working knowledge of healthcare-related regulations Demonstrates in-depth knowledge of preparing a submission Demonstrates in-depth knowledge of industry and competitive products Applies relevant regulations and statutes to further product submissions of basic to medium complexity Contributes to the strategic direction of regulatory pathway development Refines and conforms the preliminary data used in the submission process Translates technical data and descriptions into reviewer-friendly content Helps to ensure that the appropriate regulatory requirements for the submission are metInteracts with regulatory body to help further product approvals or clearanceHas in-depth experience, knowledge and skills in own job family Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance Usually determines own work priorities Acts as a resource for colleagues with less experience