Labeling Program Manager
Labeling Program Manager
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$ 116000 - 174000
1 Vacancy
Job Description
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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:
- Bachelors 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
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.
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Medtronic benefits and compensation plans
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local law. In addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Manager
Employment Type
Full-Time
