Sr. Associate, Labeling

Position Purpose

Technical writing to support Regulatory Labeling and User Manual development across medical device portfolios. This role focuses on creating editing and maintaining user manuals using structured content approaches (XML formatting tools e.g. Madcap Flare) while partnering closely with Regulatory Affairs Labeling R&D and Translation teams.

The role also supports development of a broad range of medical device documentation by translating engineering and product inputs into clear accurate and compliant content.

In addition to authoring responsibilities this role supports end-to-end labeling content execution activities including coordination of translations and alignment of labeling content across global and local markets.

Functional/technical
know how:

Individual must be flexible and capable of prioritizing projects meeting deadlines and working well under pressure. Must have strong interpersonal organization communication (both oral and written) proofreading and basic project coordination skills.

Demonstrated ability to:

• Interpret technical specifications engineering documentation and product requirements
• Translate technical information into clear user-focused documentation
• Work with structured content and/or XML-based authoring environments
• Support development of diagrams visuals and supporting materials
• Operate within defined processes and regulatory requirements

Fundamental knowledge of labeling development technical writing and regulated environments is required.

Major Accountabilities (Limited to 5-7 bullet points)

Technical Writing & Content Management

• Develop edit and maintain user manuals and regulatory labeling content for medical devices (including surgical and/or software products)
• Author structured content using XML-based formatting tools (preferred: Madcap Flare or similar)
• Migration of legacy documentation (Word PDF and other unstructured formats) into structured authoring tools (for example Madcap Flare) ensuring standardization and content reuse
• Interpret engineering and product inputs into clear accurate and compliant documentation
• Ensure content aligns with regulatory quality and usability standards

Content Development & Review

• Ownership of content lifecycle management including version control change impact assessment and updates across product releases.
• Acquire subject matter knowledge through collaboration with R&D engineering and SMEs and by reviewing technical specifications and supporting documentation
• Support development and selection of illustrative materials (diagrams charts visuals)
• Perform quality reviews for clarity consistency and completeness
• This role does not have final review and approval of documentation - this is managed by appropriate SMEs

Translation Coordination

• Coordinate translation activities for labeling and user manuals
  • Manage handoffs to translation vendors/tools
  • Track progress timelines and deliverables
• Review translated documents for formatting completeness and alignment (not responsible for translated content itself)

Systems & Tools

• Work within and across systems such as:
  • Madcap Flare (preferred) or other XML authoring tools
  • Teamcenter (preferred experience) for content and change context
• Support structured content management and integration with broader labeling systems
• Utilize Adobe tools (e.g. Illustrator Photoshop) for content support as needed

CrossFunctional Collaboration

• Partner with Regulatory Affairs Engineering Product Development and Quality
• Ensure alignment between technical requirements labeling content and downstream outputs (e.g. artwork manuals)
• Support documentation deliverables within defined project timelines

Background:

Education:

• Minimum: Bachelors degree Technical Writing Journalism or English or technical degree

Languages:

• Fluency in English essential

Experience/Professional Requirement:

• Minimum: 2-5 years technical writing/labeling experience in the medical device or pharmaceutical industry
• Experience developing technical documentation for electromechanical or software-based products preferred
• Experience developing user manuals IFUs service manuals and/or other regulated documentation aligned with global standards.
• Familiarity with regulated environments (e.g. EU MDR IEC 60601) preferred
• Exposure to structured content and/or XML authoring tools preferred

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