The Regulatory Affairs Specialist I 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 I 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.
- 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 with
- Ability to remain calm and receptive in fast paced situations.
- 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.
- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.
- International and domestic travel as required.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.