Work Flexibility: Hybrid

Purpose of job:

Responsible for managing and guiding the development and approval of complex medical device Labeling (Information for Use) content within the context of established policies, procedures, and processes in support of growth and sustaining business initiatives with minimal oversight.
Supporting global business functions, serving internal and external customers.
Lead product use information initiatives across department functions – compliance, process, software, hardware, manufacturing and documentation.
Manages assigned labeling projects and is responsible for all aspects of the assigned projects from initiation to completion, including the definition of project goals, priorities and resources needs
Demonstrates commitment to patient safety and adhere to organizations global quality policy and company values.

Key responsibilities

Responsible to create and maintain independently compliant Labeling acc. to international standards and regulations as well as support of interacting disciplines (e.g. Risk, Packaging, Medical/Clinical, RA) from the very start point until release.
Supports new technologies / systems deployed to enhance product labeling, development, and review processes.
Manage individual or labeling team projects in support of new medical device development, product life cycle management and new regulations.
Utilize a variety of specialized tools to support labeling: desktop publishing, specialized label software, translation workflow management software, PLM/CMS system for labeling releases/updates, translation memories.
Participate in internal and external audits as a product labeling expert.
Resolve non-conformances by identifying root causes and developing corrective actions.
Supports M&A due Diligence activities.
Assesses Standards and Regulations, interpret them and also develop the implementation strategy also in regards to CIDTs or Quality Agreements.
Process Owner including consequent reviews and Improvements, but also the development of best practice documents.
Organize and train end users in labeling business & system processes.
May perform other duties as assigned.
Support multiple concurrent, complex labeling projects for new products, mergers and acquisitions, and sustaining.

Competences

Understanding of medical device labeling with knowledge of regulatory requirements.
Fully understand and be able to apply global labeling standards and regulations. Additionally, be able to coach and mentor others on the team in this area of expertise.
Able to apply fundamental and advanced concepts, practices, and procedures related to labels.
Excellent problem solving and analytical ability.

Education/Training

Experience

5 to 7 years’ work-related experience
Experience with label software and database structures required (SAP, SLS, Bartender, Innovatum, Prysim, etc.).

#IJ

Travel Percentage: 10%

Staff Labeling and Technical Publication Specialist

Job Description