Top Regulatory Affairs Executive oversees all regulatory matters and creates the overall 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 Top Regulatory Affairs Executive 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, Top Regulatory Affairs Executive investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to top management. The Top Regulatory Affairs Executive manages a business unit, division, or corporate function with major organizational impact. Establishes overall direction and strategic initiatives for the given major function or line of business. Has acquired the business acumen and leadership experience to become a top function or division head. (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 - $57,531.55 per year
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Work Location: In person
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