Labeling Specialist

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 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.

Responsibilities:

• Plans projects and manages scope, deliverables and timelines using project
management tools, managing communication with stakeholders and managing project
teams to keep deliverables aligned with business objectives and priorities.
Effectively engages with the project team and seeks out support when
appropriate

• Fosters a collaborative environment. Gains support and cooperation for ideas,
proposals, projects and solutions to accomplish goals

• Is a subject matter expert of labeling regulations and standards

• Understands all procedures impacting the design and development of product
labeling

• Able to translate customer needs into labeling requirements

• Develops and executes labeling documentation and labeling per business
processes and policies

• Continuously builds knowledge, keeping up-to-date on the technical or
procedural aspects of the job

• Takes into account cause and effect relationships when making decisions.
Aligns one’s objectives with the Packaging and Labeling and business strategies
in order to make the best possible judgments. Familiar with continuous
improvement tools such as DMAIC/A3 and root cause

• Writes effectively, gathers and compiles data and translates it into easily
understandable documents,

• Utilize good documentation practices (i.e. revision control, red lining,
Agile release)

• Experience working on multi-disciplinary teams and projects.

• Highly detail oriented

• Experience working 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.

To know more about this opportunity, please contact:

Sagar Rathore

sagar.rathore(at)collabera.com
630-485-2166