Regulatory Affairs Associate - #256936
Experis
Date: 2 days ago
City: Santa Clara, CA
Contract type: Contractor
Title: Regulatory Affairs Associate
Location: Santa Clara, California
Duration: 6 Month
100% Onsite
Pay Range: 45/hr W2
Responsibilities
Location: Santa Clara, California
Duration: 6 Month
100% Onsite
Pay Range: 45/hr W2
Responsibilities
- 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 guidance 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
- 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.
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