Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
ISG is recruiting for a local leading medical device company in Norfolk, Virginia, they are dedicated to improving healthcare outcomes through innovative products. As a company committed to quality and compliance, they are seeking a talented Regulatory Affairs Specialist to join the team and oversee the 510(k) submission process to the FDA.
Job Description:
As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with FDA regulations for medical devices. You will be responsible for managing the entire 510(k) submission process, from initial preparation to final approval. This role requires a keen attention to detail, strong communication skills, and a thorough understanding of regulatory requirements in the medical device industry.
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Job Types: Full-time, Contract
Pay: $47,771.73 - $65,000.00 per year
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Work Location: Hybrid remote in Virginia Beach, VA 23462
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