Global Regulatory Affairs Specialist II (Medical Devices)

Cook Medical Inc.; Vandergrift (Westmoreland County); On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Medical Inc. is seeking a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for medical devices in specified markets. You will develop regulatory strategies, obtain approvals, and act as a communication liaison between Cook Medical and local offices/distributors.

The role requires staying informed on ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and related regulations, and managing documentation and post-market activities as needed.

Qualifications

• Proficient in reading, writing and speaking English language.
• Bachelor’s degree in relevant technical or scientific discipline.
• Knowledge of medical device quality standards and regulatory requirements.
• 3 years of experience in the medical device industry.
• Computer experience with working knowledge of Microsoft Office.

Responsibilities

• Maintain understanding of global medical device regulations (ISO 13485, MDR 2017/745, FDA 21 CFR Part 820).
• Serve as liaison between Cook manufacturer and Local Office/Distributor/Notified Body.
• Prepare regulatory submissions for new products and changes.
• Create, organize, and maintain technical documentation.
• Maintain registration information and ensure timely re-registration.

Skills

Regulatory affairs knowledge

English communication

Project management

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in relevant technical or scientific discipline

Tools

Microsoft Office

Job description

Cook Medical Inc. is seeking a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for medical devices in specified markets. You will develop regulatory strategies, obtain approvals, and act as a communication liaison between Cook Medical and local offices/distributors.

The role requires staying informed on ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and related regulations, and managing documentation and post-market activities as needed.