Senior Labeling Specification Specialist at Medtronic

Posted in General Business 16 days ago.

Type: Full-Time
Location: Santa Ana, California





Job Description:

Careers that Change Lives
In this role, you'll be working in the Operations Innovation group and coordinating labeling activities for the following Operating Units - PVH, CRDN, Structural Heart/Aortic, and Cardiac Surgery.

You can grow your career with us; we hope you'll consider joining our team!

A Day in the Life
• Create, review, and reproduce text required for labeling medical products
• Ensure that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements
• Monitor changes in labeling regulations in the US and/or abroad
• Review promotional and commercial communication material and ensures that it is supported by the data and consistent
with the application
• Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies
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 Haves
• Bachelor's Degree and 4+ years of Packaging or Labeling experience OR advanced degree and 2+ years of Labeling experience

Nice to Have
• 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 or pharmaceutical 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)

A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).





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