Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established 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 Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (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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