Regulatory Affairs Specialist

Spectraforce Technologies
United States, California, Irvine
Aug 20, 2025
Regulatory Affairs Specialist Location: Irvine, CA Duration: 15 months Description: Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval in SEA and Korea. 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 met. Interacts with regulatory body and internal stakeholders to help further product approvals or clearance. Review and approve product labeling/advertising for compliance to country-specific regulations Has in-depth experience, knowledge and skills in own job family. Applies knowledge and skills to a wide range of standard and non-standard situations. Maintain accurate records of submissions, approvals, and correspondence in compliance with company procedures and global standards. Works independently with minimal guidance. Usually determines own work priorities Acts as a resource for colleagues with less experience Perform additional responsibilities as assigned.