Regulatory Affairs Operations Manager

Posting Date 1 month ago(6/15/2021 5:22 PM)
Requisition ID
2021-9155
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

The Manager of Regulatory Affairs Operations manages the day-to-day operations of the Regulatory Affairs Team within an assigned product area or regional area to help ensure the process produces effective regulatory submissions and timely regulatory approvals.

Responsibilities

- Manage team members workload and work flow of assigned regulatory area.
- Communicate directly with RA leadership on proposed improvements.
- Lead all efforts related to data collection, data management, data reporting and database management for the Regulatory Affairs Department.
- Actively pursue ways in which to improve the function of the Regulatory Affairs Department.
- Communicate directly with regulatory agencies and distributors.
- Manage the progress of RA 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 Regulatory experience in the medical device field and/or 4 years Regulatory experience with Cook Medical.
- Bachelor’s degree in a science related field; or experience of such kind and amount as to provide a comparable background.
- Expert knowledge of Microsoft Office and database management.
- 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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