Regulatory Engineer Manager

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 withminimal 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.