Regulatory Affairs Associate

hace 2 semanas

Xico, México Clinchoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring?Our team says it's the best of both worlds....ClinChoice is searching for a Regulatory Affairs Associate Consultant for 12 months Contract with possibility of extension to join one of our clients.ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture.As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.Job Title: Regulatory Affairs Associate - CONSULTANT Location: Mexico Remote Responsibilities: Collect, review, and upload product, licensed product and license data in databases (e.g., UDI, eligibility, etc.) Review, execute and drive eligibility releases as per required procedures Review, track and monitor critical Notified Body mailbox and invoices On a project/product basis, facilitate change orders for DEC/DoC/DD and other documents in the PLM system(s), and assist with strategy creation, follow-up on local assessments and creation of relevant documentation (e.g., letters to file) Maintain/update in all relevant databases and sources (e.g., GRID for document self-serve) On a project basis, monitor, track and execute regulatory operational processes as required Perform other tasks as required Minimum Requirements: Bachelor's degree (life sciences preferred) Basic knowledge of US FDA QSR, ISO*****, EU MDD/MDR Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint) Strong proficiency in written and verbal English communication is required.

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