We anticipate the application window for this opening will close on - 15 Jul 2025

 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

We are seeking a highly skilled and collaborative Labeling Program Manager to lead and manage complex labeling programs across our Surgical Operating Unit. In this critical role, you will be the strategic and operational hub of labeling efforts, ensuring the timely development, review, and release of Instructions for Use (IFU) and related documentation.

 

You will work cross-functionally with Product Release, Configuration Assurance, Technical Writing, Graphics, and Translation teams to align labeling deliverables with both regulatory requirements and program milestones. You will also serve as a key liaison between labeling contributors and product development teams to support product launches and updates in global markets.

 

Key Responsibilities:

• Responsibilities may include the following and other duties may be assigned:
• Lead and manage complex labeling programs, ensuring all schedules, milestones, deliverables, and resources are aligned with business goals.
• Act as the central liaison for labeling strategy, planning, development, and logistics across internal and external teams.
• Coordinate with Configuration Assurance to initiate and route Engineering Change Orders and Change Actions (CO/CAs).
• Direct and support technical writers and graphic designers in developing high-quality, compliant IFU deliverables.
•  Serve as the labeling representative on high-level product development teams.
• Collaborate with Medtronic Translations to initiate and prioritize translation projects, monitor progress, and report on status to stakeholders.
• Proactively identify labeling interdependencies and communicate with project/program managers to mitigate risks and delays.
• Ensure labeling deliverables meet quality standards and are released on schedule.
• Drive activities related to the qualification and release of eManuals for product launches.
• Support cross-functional initiatives aimed at improving labeling processes and cross-business collaboration.
• Contribute to internal process optimization, documentation standards, and efficiency initiatives within the labeling function.

 

Must Haves:

• Bachelor’s degree AND minimum of 5 years of relevant experience OR
• Advanced degree with 3 years relevant experience

Nice to Have:

• Strong understanding of FDA and international labeling regulations (e.g., EU MDR, ISO standards)
• Experience working with cross-functional teams in a matrixed environment
• Exceptional communication, organization, and stakeholder management skills
• Familiarity with document control systems and change management processes
• Experience in medical device labeling or technical communication
• Background in surgical, robotics, or digital technologies
• Knowledge of translation processes and global labeling compliance
• Experience with eManuals systems and/or regulatory publishing platforms
• PMP certification or similar project management credential
• Comfortable working in a fast-paced, evolving environment with multiple priorities

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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 o