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Regulatory Affairs Associate"

Spectraforce Technologies
United States, California, Santa Clara
Apr 01, 2025
Job Title: Regulatory Affairs Associate Location: Santa Clara, CA, 95054 Duration: 12 months Description / Summary: This role will provide support to the Regulatory Affairs organization by - Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system, Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidances are met, Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance. Driving quality system process improvement initiatives Initiatives include but are not limited to: Establishing emerging issues in our quality system, Maintaining the quality system procedures (e.g. change management), Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements, Troubleshooting with regulatory affiliates, and Participating in RA projects. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus. List of tasks: CFG requests in the FDA database. Declarations of conformity. Review Regulatory Letters and maintain LoA / PoA tracker. Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters. Maintain tracker / SharePoint / folders with current state. Change management Skills: Independent Troubleshooting Critical thinker Ability to drive a problem through resolution and implement mitigations. Ability to handle multiple streams simultaneously.