Risevoic
Regulatory Engineer
Company : Cook Medical
Location : Bloomington, IN, 47404
Job Type : Full Time
Date Posted : 11 January 2026
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
- 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 withminimal supervision.- Ability to remain calm and receptive in fast paced situations.
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. - Travel as required
- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA
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Frequently asked questions
In Bloomington, regulatory engineers often boost their profiles with certifications like RAC (Regulatory Affairs Certification) or PMP for project management. These credentials align well with FDA and global compliance demands, increasing employability within medical device sectors such as Cook Medical.
Bloomington’s proximity to major medical device hubs creates steady demand for regulatory engineers skilled in FDA submissions and international compliance. While the market is competitive, specialized expertise in regulatory documentation and cross-functional coordination notably enhances hiring prospects.
Handling diverse engineering inputs while ensuring alignment with varying international standards forms a key challenge. Regulatory engineers must navigate complex documentation, troubleshoot gaps in compliance, and communicate effectively with global teams to meet submission deadlines.
Regulatory engineers often progress towards senior regulatory specialist or regulatory affairs manager roles. Gaining experience in technical writing, submission strategy, and cross-functional leadership enhances promotion potential within companies like Cook Medical and the broader medical device industry.
Beyond regulatory knowledge, strong technical writing and engineering background are vital. Regulatory engineers bridge engineering and regulatory teams, requiring problem-solving skills and ability to interpret technical project data for FDA and international submissions.
Cook Medical emphasizes collaborative problem solving and adherence to quality systems, which shapes the regulatory engineer’s role to be both independent and team-oriented. The company’s global footprint demands clear communication and proactive regulatory strategy execution.
Cook Medical combines innovative medical device development with rigorous FDA compliance, requiring engineers to be deeply involved in technical and regulatory liaison. Their global operations add complexity, making adaptability and cross-cultural communication especially important.
Regulatory Engineers in Bloomington generally earn between $75,000 and $95,000 annually, reflecting regional demand and cost of living. This falls slightly below high-cost areas but remains competitive due to the specialized FDA and medical device expertise required.
They conduct technical assessments of change orders, ensuring engineering outputs meet FDA criteria. Their role includes drafting precise submissions and coordinating approvals, which helps maintain continuous compliance and smooth regulatory processes.
Some believe regulatory engineers need constant oversight; however, professionals in this field often operate independently, managing complex submissions and cross-department collaborations with minimal supervision, especially in established firms like Cook Medical.