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

A Day in the Life

Medtronic pioneered the field of neuromodulation with groundbreaking innovations including the first commercially available spinal cord stimulator for chronic pain the first deep brain stimulation (DBS) system for movement disorders and the first implantable drug pump for targeted medication delivery to the intrathecal space of the spine. More than 40 years later we continue to push the boundaries of innovation constantly challenging ourselves to disrupt the markets we created. By advancing science with bold thinking and collaboration we bring together the right expertise to engineer groundbreaking therapies and technologies that transform patient care.

Join a diverse team of innovators who bring their worldview their unique backgrounds and their individual life experiences to work every day. Its no accident we work hard to cultivate a workforce that reflects our patients and partners. We believe its the only way to drive healthcare forward and remain a global leader in medical technology and solutions.

#Neuroscience

Careers That Change Lives

This role of Principal Labeling Specification Specialist requires the management and execution of tasks and deliverables specific to medical device labeling products for various projects within the Medtronic Neuroscience portfolio. Primary responsibilities include the production of customer-facing product documentation including but not limited to user guides service manuals and instructions for use (IFUs) which encompass both clinician and patient labeling accompanying our Neuroscience medical device products. This role will directly support R&D projects such as new product development and released products maintenance (e.g. sustaining activities and legacy document updates) as well as quality- and compliance- driven projects to ensure our labeling conforms to quality assurance standards and labeling requirements from external standards and regulations (e.g. FDA EU MDR ISO etc.). Additionally this role will include accountability for both the content in the labeling as well as the supporting documentation which may include design plans design input requirements and tracing documents review documentation and verification reports. Responsibilities may also include supporting the investigation documentation and resolution of labeling-related quality issues.

Responsibilities may include the following and other duties may be assigned:

• Supports the Neuroscience labeling team in developing and executing on project timelines for programs that impact or include the creation of or update to labeling content.

• Collaborates with departmental and cross-functional peers to ensure proper resolution to labeling-related and issues during the development process.

• Creates and reviews text required for labeling medical products.

• Ensures compliance of labeling with all applicable regulatory/QSR requirements.

• Monitors evaluates and recommends improvements to labeling processes quality systems tools and/or policies.

• Continually reviews the document development process to ensure quality in labeling output.

• Manage all aspects of document development and assist in production release including draft reviews and formal labeling approvals coordination of translations and initiating CO/CA release.

• Revise edit and format legacy product documentation as required including but not limited to users guides service manuals instructions for providers (IFPs) and instructions for use (IFUs).

• Deliver supporting documentation for the labeling product including labeling design plans trace documents technical reviews and verification deliverables.

• Effectively manage multiple projects changes in project scope and shifting priorities to maintain project requirements and ensure deadlines are met.

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident on your resume.

• Baccalaureate degree

• Minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.

At Medtronic we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. Were working onsite 4 days a week to drive performance foster an environment of belonging and collaborate to inspire as we engineer the role will require no travel.

Nice to Have (Preferred Qualifications)

• Self-directed and highly organized; meticulous in nature

• Cross-functional collaborative nature: strong collaboration and communication skills to work with diverse teams

• Product Lifecycle Management software experience

• Content Management software experience

• Working in a federally regulated environment (FDA)

• European Union Medical Device Regulation (EUMDR)

• Medical device labeling-related experience

• Familiar with the principles of neuromodulation

• Familiar with product development workflow

• Ability to manage multiple priorities

• Familiarity with Quality/CAPA processes and principals

• Excellent communication skills

• Advanced writing/editing skills

• Medical terminology experience

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 addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.