Job Description

A Day in the Life
 
In this exciting role as a Labeling Specification Specialist at Medtronic's Mounds View, Minnesota location, you will be responsible for supporting the development of medical device labeling for the Structural Heart and Aortic, Peripheral Vascular Health and Coronary and Renal Denervation businesses by coordinating across functions as well as with multiple US and international sites. You will provide project support and orchestration of labeling development activities interfacing with Marketing, R&D, Regulatory, Technical Communications, Legal, Quality and Package Engineering, site Operations, and other relevant business partners.

Lead cross-functional collaboration and influence the scope of changes and labeling requirements.
Own development of the Labeling Plans and related documentation in accordance with overall project implementation plan.
Coordinate project plan for labeling activities to meet timelines and provide inputs and support overall project plan based on label development requirements
Clearly communicate product and project requirements to the labeling design team to ensure timely and accurate execution of key deliverables.
Review product labeling including labels, cartons, IFUs and other related materials ensuring that they meet all business, medical, legal, and regulatory requirements and standards for medical devices.
Manage the review and approval process for all new and revised labeling content.
Understands applicable global labeling regulations and standards.
Coordinate the translations of non-IFU labeling through internal or external sources.
Provide input in the creation of and compliance with standards and documented procedures for labeling development, revision and overall document management.

Must Have: Minimum Requirements

Bachelors degree required
Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have (Desired Qualifications)

Minimum of 4 years' experience in packaging, labeling or relevant regulated industry
Experience managing complex projects on cross-functional teams
Highly detail-oriented
Experience working in business systems including Excel and other Microsoft Office programs
Comfortable learning and using new computer systems and program
Experience working in the medical device, Pharmaceutical or related industry

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)