Overview
The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.
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
Qualifications
- 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
Physical Requirements:
- Works under general office environmental conditions
- Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.
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