Labeling Specialist

Job Description

Labeling Specialist – This position will be a subject matter expert in Medical Device labeling regulations and standards.

They will be responsible for planning, development and execution of product labeling for Medtronic Structural Heart Businesses by coordinating and communicating across functions, as well as across multiple US and international sites. Key responsibilities include project planning, leading the development of technical labeling content and navigating the QMS, PDP and PLM workflows to execute labeling.

• Plan projects and manage scope, deliverables and timelines using project management tools, manage communication with stakeholders and project teams to keep deliverables aligned with business objectives and priorities. Effectively engage with the project team and seek support when appropriate.
• Foster a collaborative environment. Gain support and cooperation for ideas, proposals, projects and solutions to accomplish goals.
• Act as a subject matter expert of labeling regulations and standards.
• Understand all procedures impacting the design and development of product labeling.
• Translate customer needs into labeling requirements.
• Develop and execute labeling documentation per business processes and policies.
• Continuously build knowledge, keeping up-to-date on the technical or procedural aspects of the job.
• Take into account cause and effect relationships when making decisions. Align objectives with Packaging and Labeling and business strategies to make the best possible judgments. Familiar with continuous improvement tools such as DMAIC/A3 and root cause.
• Write effectively, gather and compile data and translate it into easily understandable documents.
• Utilize good documentation practices (revision control, redlining, Agile release).

• Experience working on multi-disciplinary teams and projects.
• Highly detail-oriented.
• Experience with project management tools, Adobe Acrobat Pro, MS Office Tools, PLM systems and ERP systems.
• Experience with medical device regulations and standards.
• BS or BA in related fields.

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