The Regulatory Affairs Specialist I at Cook Inc. is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified Class I, II, III and IV medical devices in specific markets. In addition to submissions, the Regulatory Affairs Specialist will serve as a communication liaison between the Cook manufacturer and the Cook Local Office / Cook Distributor.
• Serve as a liaison on regulatory issues between the Cook manufacturer 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
• Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions
• Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
• Collaborate with Regulatory Scientific Affairs on all high risk devices and new technologies
• Collaborate with the Clinical Functional Unit on projects requiring the collection of clinical data
• Provide support to currently marketed products as necessary including input on change requests, etc.
• Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations
• 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
• Proficient in reading, writing and speaking the English language
Prefer a highly experienced (10 or more years) regulatory professional. Medical devices and documented international expertise will be favored. A degree in a science or engineering field, such as a BME, PARMD or Legal would be beneficial. Computer Science, MBA or Library Science or medical writing would also be considered.
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required
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.