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Regulatory Affairs Associate

Company: Planet Pharma
Location: Santa Clara
Posted on: November 19, 2022

Job Description:

This role will provide 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 systemb. Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance's are metc. Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submissiond. Driving quality system process improvement initiatives. Initiatives include but are not limited to:1. Establishing emerging issues in our quality system2. 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 requirements4. Troubleshooting with regulatory affiliates5. Participating in RA projects. Role has a potential for investigating non conformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.

  • BACKGROUND/EXPERIENCE: 2+ years of experience

    Pay Range: $36/hr - $41/hr **Compensation within this range will be commensurate with level of experience**

Keywords: Planet Pharma, Santa Clara , Regulatory Affairs Associate, Other , Santa Clara, California

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