The Regulatory Affairs Specialist II at Cook Inc. is responsible for narrowly focusing on a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak, read and write in business level region specific language for purposes of communicating with regulatory authorities and international local Cook offices or distributors. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.
• Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner
• Communicate Country/region-specific regulatory requirements to the Regulatory Specialist/Regulatory Science team leaders and assist with the regulatory strategies
• Develop regulatory strategies, obtain and maintain product approval, and serve as a communication liaison on regulatory issues between the Cook manufacturer and the Cook International Local Office and/or Cook Distributor
• Plan and prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific countries/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
• Perform translation activities
• 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 life science (preferably biology or chemistry), engineering, or other related field (such as law); or experience of such kind and amount as to provide a comparable background
• Proficient in reading, writing and speaking region specific language (Korean) - required
• Proficient in reading, writing and speaking Mandarin - preferred
• Requires occasional early morning or late evening teleconferences
• International and domestic travel as required