Regulatory Engineer

Cook Medical • Bloomington, IN

77d

About The Position

The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.

Requirements

• BA/BS Degree in an Engineering or Science related field required; or experience of such kind and amount as to provide a comparable background
• Experience in a FDA regulated environment and/or medical device is preferred
• Must have technical writing capabilities and strong verbal communication skills

Responsibilities

• Act as liaison to engineering functions globally and locally to provide technical support for Regulatory Affairs
• Develop new, and refine existing, systems that provide the necessary information for successful submission to global regulatory bodies
• Help align engineering procedures and project outputs with regulatory requirements
• Assist various Regulatory Affairs staff with technical assessment and writing of regulatory submissions and responses to regulatory agencies
• Prepare regulatory submissions for new products, product changes, and re-registrations, as required
• Perform and/or coordinate required assessments for change orders and facilitate approval
• Provide product knowledge and training for Regulatory functional unit
• Coordinate regulatory initiatives and drive to completion
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to understand the purpose of a Quality System, and to effectively and efficiently complete work within guidelines of the Cook Inc Quality System
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity standards
• Must have effective communication skills and ability to work in a collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations

What This Job Offers

• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees