Labeling Project Specialist

Posted 21 Days Ago
Be an Early Applicant
Budapest, HUN
In-Office
Entry level
Healthtech • Manufacturing
The Role
Coordinates medical device labeling throughout its lifecycle, including IFUs, product labels, packaging labels, reviews, approvals, releases, and change control. Partners with Regulatory, Quality, Clinical, Technical Writing, Product Management, and other stakeholders to ensure accurate, compliant, consistent documentation. Manages timelines and deliverables, reconciles feedback, reviews technical content, maintains labeling standards, and performs minor updates using documentation and design tools.
Summary Generated by Built In

Join our team as a Labeling Coordinator

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999 the company utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas.

The goal is to support enduring change in clinical practice that reduces challenges of respiratory patients, improves healthcare outcomes, and alleviates cost.

Sentec applies latest scientific results and engineering technologies across the three core platforms transcutaneous monitoring, intrapulmonary percussive ventilation and electrical impedance tomography. The company researches, develops and manufactures all products exclusively in-house.

Sentec earned Kununu’s Top Company award in 2025 and 2026.
The Labeling Coordinator is responsible for the strategy, coordination, and lifecycle management of labeling that accompanies Sentec products, including Instructions for Use (IFUs), product labels, packaging labels, and other regulated labeling materials. Serving as the central point of coordination for labeling activities, this role leads labeling projects from planning through release, partnering with Technical Writing, Regulatory Affairs, Quality, Clinical, Product Management, and other stakeholders to ensure labeling is accurate, compliant, consistent, and aligned with product requirements. The Labeling Coordinator oversees content development, facilitates cross-functional reviews, resolves feedback, and maintains labeling standards, terminology, and change control processes to support a clear and effective user experience.
Tasks

Stakeholder Coordination & Project Management

  • Coordinate the development, review, approval, and maintenance of labeling across the product lifecycle, including IFUs, package inserts, device and packaging labels, and other customer-facing labeling content, according to Sentec’s QMS
  • Plan, coordinate, and track labeling projects end-to-end, managing timelines, deliverables, dependencies, and approvals
  • Collect, consolidate, and reconcile information from all relevant stakeholders (R&D, Clinical, Regulatory, Quality, Product Management, Marketing, and Service)
  • Critically review and challenge technical and clinical content together with the responsible subject-matter and clinical experts to ensure accuracy and completeness
  • Oversee labeling compliance with applicable global regulatory requirements, internal quality system requirements, and relevant industry standards across all markets.
  • Drive labeling deliverables through internal review, release, and change-control workflows

Labeling & Technical Writing

  • Able to autonomously perform minor changes to labeling documentation, label creation, and IFU updates, using various formatting and documentation tools (e.g., BarTender, Illustrator, InDesign, Word).
  • For larger projects, close collaboration with the technical writer.

Requirements
  • Proven ability to manage documentation projects autonomously – coordinating multiple stakeholders, setting priorities, and meeting deadlines
  • Distinguished writing and communication style.
  • Experience managing medical device labeling in a regulated environment, with a strong understanding of labeling requirements, change control, compliance, and lifecycle management.
  • Strong attention to detail, grammar, and clarity in documentation
  • Strong interpersonal and collaboration skills, comfortable working in an international, cross-functional team
  • Education in life sciences, engineering, regulatory affairs, communications, or related discipline.
  • Fluent in English; any other language is a plus

Benefits
  • Meaningful activity on products that enable a personalized therapy for patients
  • Flat hierarchy, short decision-making processes, interdisciplinary collaboration
  • Opportunity to contribute and develop your skills in an agile company

Policy for unsolicited applications from recruiters and recruitment agencies

We do not accept any unsolicited applications from recruiters or recruitment agencies without a prior written agreement between both parties. Therefore, we will not be liable for any commission, fee, or expense for candidates submitted spontaneously. Any application sent without a prior agreement will be considered a direct application and will not be subject to any commission rights.

Skills Required

  • Ability to manage documentation projects autonomously, coordinate multiple stakeholders, set priorities, and meet deadlines
  • Strong writing and communication skills
  • Experience managing medical device labeling in a regulated environment
  • Understanding of labeling requirements, change control, compliance, and lifecycle management
  • Strong attention to detail, grammar, and clarity in documentation
  • Strong interpersonal and collaboration skills in an international, cross-functional team
  • Education in life sciences, engineering, regulatory affairs, communications, or a related discipline
  • Fluency in English
  • Additional language proficiency
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The Company
Year Founded: 1999

What We Do

Sentec AG is a Swiss-American medical device company specializing in respiratory care, developing, manufacturing, and marketing innovative high-tech sensors and non-invasive monitoring solutions.

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