Labeling Assurance Manager

Posting Date 2 months ago(11/29/2021 2:25 PM)
Requisition ID
2021-9921
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Inc.
Category
Regulatory Affairs

Overview

The Labeling Assurance Manager manages day-to-day operations and provides leadership and direction to the functional team. Process owner for medical device graphic labeling design.

Responsibilities

- Establish expectations and requirements for labeling content, IT label system management (Prisym and enLabel IPM software), and other applicable application for Cook Inc.
- Manage all aspects of successful transfer and sustaining of labeling content into the Cook Inc. manufacturing system.
- Manage individuals responsible for label/IFU/patient facing documents/additional labeling material design and revision.
- Provide oversight of labeling application process and labeling systems (Adobe InDesign, Prisym and enLabel IPM software).
- Stay current with new and existing labeling regulations and requirements to ensure consistent and compliant labeling practices in adherence to Cook Inc.’s Quality Management System.
- Coordinate with Cook entities to ensure proper in-country labeling.
- Act as sponsor and champion for any labeling issues, e.g. CAPAs.
- Maintain understanding of industry best practices as they relate to medical device labeling global regulations.
- Work with global branding to develop and transfer global Cook labeling design elements and practices.
- Must liaise and interact effectively and professionally with and for others throughout various levels of the global organization, including Product Development, Sustaining Engineering, Regulatory, Supplier, etc.
- 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, EU MDR, TGA 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

- BS in related field preferred; or experience of such kind and amount as to provide a comparable background.
- Minimum 5 yrs experience working in a medical device labeling or similar experience preferred.
- Experience with Adobe InDesign, Prisym and enLabel IPM software preferred.
- Proficient in Microsoft Word/Excel/Outlook.

 

Physical Requirements:

- Works under general office environment conditions.
- Utilizes close visual acuity for working with computers and equipment.
- Frequently required to sit, stand, walk, and communicate.

- Must be able to perform the essential functions of the job, subject to reasonable accommodation requirements under the ADA.  

**Qualified candidates must be legally authorized to be employed in the United States.  Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) of this employment position.**

 

 

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