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Regulatory Affairs Associate

Santa Clara, CA 95054

Posted: 03/16/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 548260 Is job remote?: No Country: United States

Job Description

 Job responsibilities: This role will provide quality, compliance and regulatory support to the Regulatory Affairs organization by – a. Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system b. Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidances are met c. Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission d. Driving quality system process improvement initiatives. Initiatives include but are not limited to: 1. Establishing emerging issues in our quality system 2. Maintaining the quality system procedures (e.g. change management) 3. Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements 4. Troubleshooting with regulatory affiliates 5. 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.

Looking for candidates that have 4-5 yrs exps in Regulatory Affairs
Exp with Submissions with FDA, NDR and PMA

Target pay: 38-43/hr
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