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 and/or Cook Distributors, supporting regulatory strategies, product registrations, and ongoing compliance.

Requirements

Bachelor’s degree in a related field preferred; an associate degree in Regulatory Affairs; or experience of such kind and amount as to provide a comparable background.
Proficiency in reading, writing, and speaking English.
Legally authorized to be employed in the United States; the company does not intend to provide employment visa sponsorship for this position.
Ability to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.

Responsibilities

Serve as a liaison on regulatory issues between Cook manufacturers and Cook Local Offices and/or Cook 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 in specific regions.
Maintain registration information, including license numbers and expiration dates, and obtain re-registration approvals before licenses expire to avoid disruption 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, 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 help achieve product approvals in a timely manner.
Maintain position training requirements and pursue opportunities for continued 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 throughout various levels of the global organization.
Adhere strictly to safety requirements.
Maintain regular and punctual attendance and meet company quality and quantity standards.
Communicate effectively and work collaboratively or independently with minimal supervision.
Remain calm and receptive in fast-paced situations.