Global Medical Devices Regulatory Affairs Specialist I

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

Job summary

Cook Medical Inc. is seeking a Regulatory Affairs Specialist 1 in Bloomington, IN to plan and prepare regulatory submissions for Class I–IV devices across regions. The role acts as a liaison between Cook and local offices/distributors to ensure timely approvals.

The candidate will maintain registration information, collaborate with regulatory science and clinical teams, and adhere to applicable regulations including FDA 21 CFR 820 and ISO 13485. Travel may be required.

Qualifications

• Bachelor’s degree or equivalent experience in regulatory affairs or related field.
• Proficient reading, writing and speaking English.

Responsibilities

• Serve as liaison between Cook manufacturer and local office/distributor on regulatory issues.
• Inform and assist with regulatory strategies and region-specific requirements.

Skills

Communication skills

Regulatory knowledge

English proficiency

Education

Bachelor’s degree in related field

Associate degree in Regulatory Affairs

Job description

Cook Medical Inc. is seeking a Regulatory Affairs Specialist 1 in Bloomington, IN to plan and prepare regulatory submissions for Class I–IV devices across regions. The role acts as a liaison between Cook and local offices/distributors to ensure timely approvals.

The candidate will maintain registration information, collaborate with regulatory science and clinical teams, and adhere to applicable regulations including FDA 21 CFR 820 and ISO 13485. Travel may be required.