The Regulatory Operations Specialist I is responsible for the supporting, planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices in specific markets by managing regulatory data, records, and documents. In addition, the Regulatory Operations Specialist I will serve as a liasion to other functions and departments as a Regulatory Affairs department representative for any regulatory data, records, and documents matter.
• Serve as a liaison on regulatory system and databases issues between the Cook manufacturers and Cook Local Office and/or Cook Distributor.
• Communicate region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assists with the regulatory strategies to build regulatory database/system.
• Manage registration information (license numbers, expiration dates, etc.) in Cook databases to ensure no disruption in product availability.
• Provide support to currently marketed products as necessary including input on change requests, etc.
• Provide support to Cook manufacturers managing registration information.
• Analyze regulatory information to generate meaningful data to support inter- and intra- Cook departments.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.
• Support communication with regulatory authorities to ensure product approvals are achieved and recorded in a timely manner.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Bachelor’s degree in a related field preferred; Associates degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background
• Experience with IT and data management and integrity required
• Proficient in reading, writing and speaking the English language
Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required; less than 10%