Regulatory Affairs Specialist I

Cook Group•Bloomington, IN

About The Position

The Regulatory Affairs Specialist I plans and prepares submissions to obtain regulatory approvals for new and modified Class I, II, III, and IV medical devices in specific markets. The role also serves as a communication liaison between Cook manufacturers and Cook Local Offices or distributors, supporting regulatory strategies and product availability across regions. The specialist collaborates with Regulatory Scientific Affairs on high-risk devices and new technologies, and with the Clinical Functional Unit on projects that require clinical data collection. The position operates under general office conditions and requires domestic and international travel as needed. Candidates must be legally authorized to work in the United States; Cook does not intend to sponsor employment visa status for this position.

Requirements

A bachelor's degree in a related field is preferred; an associate degree in Regulatory Affairs or experience providing a comparable background is also acceptable.
Proficiency in reading, writing, and speaking English.
Must be legally authorized to be employed in the United States.
Ability to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

Nice To Haves

Bachelor's degree in a related field preferred.

Responsibilities

Serve as a liaison on regulatory issues between Cook manufacturers and Cook Local Offices and/or distributors.
Communicate region-specific regulatory requirements to Regulatory Specialist/Regulatory Science team leaders and assist with regulatory strategies.
Prepare regulatory submissions for new products, product changes, and re-registrations as required for specific regions.
Maintain registration information, including license numbers and expiration dates, and obtain re-registration approvals before license expirations to prevent disruptions in product availability.
Collaborate with Regulatory Scientific Affairs on high-risk devices and new technologies.
Collaborate with the Clinical Functional Unit on projects requiring clinical data collection.
Support currently marketed products as necessary, including providing input on change requests.
Maintain and organize regulatory records to demonstrate compliance with applicable regulations.
Communicate and interface directly with regulatory authorities to achieve product approvals in a timely manner.
Maintain position training requirements and pursue 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.
Work and interact effectively and professionally with others at various levels of the global organization.
Strictly adhere to safety requirements.
Maintain regular and punctual attendance.
Meet company quality and quantity standards.
Communicate effectively and work collaboratively and independently with minimal supervision.
Remain calm and receptive in fast-paced situations.