The Senior Regulatory Affairs Operations Specialist will lead activities to drive alignment and consistency across the Endoscopy RA Organization, throughout the product lifecycle. Working closely with functional leadership, this position will focus on continuous improvement of Endoscopy RA data, processes, systems, and documents, and support projects to drive standardization and automation.
Your responsibilities include:
• Researching and documenting 510(k) history, including but not limited to:
o Generate a clearance/approval chronology in a prescribed format for each commercial device, verifying the 510(k) to product linkage as well as applicable Letters to File
o Verifying FDA Product Codes for all 510(k) exempt devices
o Reformatting regulatory data into a prescribed format for system upload
• Organizing paper and electronic 510(k) documentation in a prescribed format
• Monitor for changes to collected data to ensure data integrity
• Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed
• Support RA systems, processes, and business process to improve the overall effectiveness of the Endoscopy Regulatory Affairs function
• Maintain regulated data for Endoscopy using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc.
• Support and maintain Quality initiatives in accordance with Quality Policy
• Continuously assess ways to improve Quality
What we’re looking for:
Required Qualifications:
• A minimum of a Bachelor’s degree in a scientific, technical, or related discipline
• A minimum of 5 years experience in Regulatory Affairs within the medical device industry
• Working knowledge of FDA and international regulations for medical devices
• General understanding of product development process and design control
Preferred Qualifications:
• Ability to manage several projects of moderate scope and complexity
• High attention to detail, task oriented, deadline conscientious
• Proficiency in Microsoft Excel with ability to convert data for more effective analysis
• Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel
• Effective research, analytical, and problem-solving skills
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently with minimal supervision
• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy
• Establishes and promotes a work environment that supports the Quality Policy and Quality System
Job Info Job Location: Sandston, VA Route Type: Local Type of Assignment: Temp to Hire Hours Per Shift: 12 Hours Hours Per Week: 84 Hours Shift Start Time: 07:00 pm Working Days: Mon-Sun Transmission Type: Automatic Job Requirements CDL...
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