3 Regulatory Affairs Engineer Jobs in Bloomington, IN
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Regulatory Affairs Engineer
$82k-104k (estimate)
Full Time | Medical Technology
3 Weeks Ago
Cook Medical is Hiring a Regulatory Affairs Engineer Near Bloomington, IN
OverviewThe Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA and international regulatory requirements.
Responsibilities
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
- 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
- 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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Medical Technology
SALARY
$82k-104k (estimate)
POST DATE
05/22/2024
EXPIRATION DATE
06/20/2024
WEBSITE
cookmedical.com
HEADQUARTERS
BLOOMINGTON, IN
SIZE
3,000 - 7,500
FOUNDED
1963
CEO
M KEM HAWKINS
REVENUE
$500M - $1B
INDUSTRY
Medical Technology
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