Labeling Specification Specialist

Medtronic

68d • $73,600 - $110,400

About The Position

The role of 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.

Requirements

• Requires a Baccalaureate degree in a technically related field minimum of 2 years of relevant experience, or advanced degree.

Nice To Haves

• 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) experience.
• 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 principles.
• Excellent communication skills.
• Advanced writing/editing skills.
• Medical terminology experience.

Responsibilities

• 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 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 user’s 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.

Benefits

• Health, Dental and vision insurance.
• Health Savings Account.
• Healthcare Flexible Spending Account.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Tuition assistance/reimbursement.
• Simple Steps (global well-being program).
• Incentive plans.
• 401(k) plan plus employer contribution and match.
• Short-term disability.
• Paid time off.
• Paid holidays.
• Employee Stock Purchase Plan.
• Employee Assistance Program.
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums).
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees