Regulatory Affairs Specialist I — Medical Devices

Cook Group; Bloomington (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

Cook Group in Bloomington, Indiana, seeks a Regulatory Affairs Specialist 1 to plan and prepare regulatory submissions for Class I–IV medical devices and to serve as liaison between Cook manufacturers and local offices/distributors.

The role emphasizes adherence to FDA 21 CFR 820 and ISO 13485, maintaining registration data, and collaborating across Regulatory, Clinical, and Quality groups to ensure timely product approvals.

Qualifications

• Bachelor’s degree preferred; Associates degree in Regulatory Affairs or equivalent experience.
• Proficient reading, writing and speaking English.

Responsibilities

• Serve as a liaison on regulatory issues between Cook manufacturers and Local Office/Distributor.
• Communicate region-specific regulatory requirements to Regulatory teams and assist with regulatory strategies.
• Prepare regulatory submissions for new products, product changes, and re-registrations for specific regions.
• Maintain registration information (license numbers, expiration dates) and obtain re-registration approvals to ensure product availability.
• Collaborate with Regulatory Scientific Affairs on high-risk devices and new technologies.
• Collaborate with Clinical Functional Unit on projects requiring clinical data collection.
• Provide support to currently marketed products including input on change requests.
• Maintain and organize regulatory records to demonstrate compliance with applicable regulations.
• Interface with regulatory authorities to ensure timely product approvals.
• Maintain training and seek opportunities for continuous development; adhere to Quality Management System and 21 CFR 820, ISO 13485.

Skills

Regulatory liaison

Regulatory knowledge

English proficiency

Education

Bachelor's degree or related field

Associates in Regulatory Affairs

Job description

Cook Group in Bloomington, Indiana, seeks a Regulatory Affairs Specialist 1 to plan and prepare regulatory submissions for Class I–IV medical devices and to serve as liaison between Cook manufacturers and local offices/distributors.

The role emphasizes adherence to FDA 21 CFR 820 and ISO 13485, maintaining registration data, and collaborating across Regulatory, Clinical, and Quality groups to ensure timely product approvals.