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