Regulatory Engineer Manager at Cook Inc. (Bloomington) in Bloomington, Indiana

Job Description:

Regulatory Engineer Manager

Requisition ID 2024-14149

Posting Date 21 hours ago (3/13/2024 8:40 PM)

Job Location(s) Bloomington IN United States

Position Type Full Time

Company Cook Inc - Bloomington

Category Regulatory Affairs

Overview

The Manager of Regulatory Engineering manages the day-to-day operations of the Regulatory Engineering Team for the development of regulatory documentation for compliance with FDA and international regulatory requirements.

Responsibilities

- Manage team members workload and work flow, serving as a liaison to engineering functions globally and locally to provide technical support.
- Excellent problem solving skills and ability to work in collaborative and independent work situations and environments.
- Help align engineering procedures and project outputs with regulatory requirements.
- Communicate directly with RA leadership on proposed improvements.
- Actively pursue ways in which to improve the function of the Regulatory Affairs Department.
- Manage the progress of RA Engineering team members on assigned tasks, and remove roadblocks.
- Helps refine and implement Regulatory practices/procedures.
- Effectively communicate with and coordinate resources.
- Manage accountability within the team to meet established time lines.
- Responsible for performance and wage reviews for team members.
- Foster and maintain a workplace culture respectful and supportive of individual differences.
- Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
- Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

- 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.

Qualifications

- Minimum 5 years Engineering, Regulatory or Quality experience in the medical device field and/or 4 years Regulatory or Engineering experience with Cook Medical.
- BA/BS Degree in an Engineering or Science related field required; or experience of such kind and amount as to provide a comparable background
- Completion of RAC preferred.
- Proven project leadership skills.
- Demonstrated ability to provide consistent leadership in a team setting.
- Demonstrated ability to manage conflict, communication & resources across multiple projects.

Physical Requirements

- Requires occasional early morning or evening teleconferences.
- Must be willing and able to travel as needed.
- Works under general office environmental conditions.
- Sits 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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"We are proud to be an equal employment opportunity employer for minorities, women, protected veterans, disabled individuals, and any other protected class."

Cook will consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state/province and local law.