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Senior Regulatory Specialist

Company: VirtualVocations
Location: Gainesville
Posted on: November 7, 2024

Job Description:

A company is looking for a Senior Regulatory Specialist to support product compliance strategies and ensure regulatory standards are met.



Key Responsibilities

Collaborate with engineering, manufacturing, and sales to generate customer part qualification packages
Maintain compliance files and respond to customer questionnaires related to product compliance
Support ongoing validation programs, including sterility and cleanroom certifications


Required Qualifications

Bachelor's degree in Science, Engineering, or related field
5+ years of experience in Quality and Regulatory roles, particularly in medical devices or biopharmaceuticals
Knowledge of cGMPs and USP/ISO Standards related to validation and biocompatibility
Strong experience with MS Office
Experience in developing and revising Standard Operating Procedures

Keywords: VirtualVocations, Palm Coast , Senior Regulatory Specialist, Other , Gainesville, Florida

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