Regulatory Affairs Specialist I

- 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.

- 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.- Communicate and interface directly with regulatory authorities to ensure product approvals are achieved in a timely manner.- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- Must work and interact effectively and professionally with and for others throughout various levels of the global organization.- Must strictly adhere to safety requirements.- Maintain regular and punctual attendance.- Must maintain company quality and quantity standards.- Must have effective communication skills and ability to work in a collaborative and independent work situations and environments withminimal supervision.- Ability to remain calm and receptive in fast paced situations.