Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (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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