The Regulatory Affairs Clerk will generate, maintain, and organize regulatory data and documentation in order to support the activities and outputs of the Regulatory Affairs Department and demonstrate compliance with applicable regulations.
- Supports the Regulatory Team as needed.
- Maintains and organizes appropriate regulatory records to demonstrate compliance with applicable regulations.
- Communicates with Cook companies, distributors, and customers.
- Communicates administrative requests to Regulatory Authorities.
- Maintains regulatory section of Cook database/ data repositories: Project tracker, global product file, global technical warehouse, device tracking database, etc.
- Performs additional duties as assigned.
- 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.
- High school diploma or GED.
- Relevant experience and a minimum of 1 year Cook experience.
- Excellent computer skills including skills with Cook databases desired.
- Must be comfortable working with and adapting to constantly changing requirements and priorities.
- Must be highly detail oriented.
- Must be able to coordinate multiple projects at one time effectively, efficiently and independently.
- Works under general office environment conditions.
- Sitting for extended periods, utilizes close visual acuity for working with computers and equipment.
- Frequently required to stand, walk, and communicate.
- Occasionally lifting with minimal exertion during shift.
- Ability and commitment to operate in a team based and/or independent work environment.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.