Labeling Specialist

Company details


BVI® is a global ophthalmic medical device manufacturer with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. The team supports surgical teams, in more than 115 countries worldwide, either directly or through our network of trusted distributors.

For its innovation unit (PhysIOL Intraocular Lenses) located in the Liège Science Park (Belgium), BVI mandated Profile Group for the recruitment of their future Labeling Specialist, to help them realize their ambitions.




You report to the Industrialization Director.

The Labeling Specialist is responsible for creating and updating labeling documentation and product information for medical device products, in order to optimize patient safety and minimize product liability risk. Works with regulatory, industrialization, marketing quality, and other internal functional areas and with external regulatory agencies to ensure timely regulatory and quality compliance, and to support business objectives as required.

Your responsibilities are the following:

  • Provides labeling, and graphic design support for new product development/initiatives as well as support commercial/on-market, sustaining products, regulatory submissions, and tenders
  • Create, revise, and control labeling, with a primary focus on documentation control through all phases of the change control process or based on quality agreement
  • Support new label process development using label softwares such as Adobe Creative Cloud, SharePoint, Prisym, BarTender, Teklynx/CodeSoft, SalesForce, and QMS/ERP (e.g., IFS)
  • Write and edit documents such as specifications, Standard Operating Procedures (SOPs) and technical documentation (IFUs, QRGs, etc.) to support labeling development in compliance with ISO, cGMP, and FDA guidelines, while working within established formats and templates
  • Coordinates production traceability set-up
  • Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives
  • Maintain a high level of quality, clarity, and consistency for all documents
  • Represent the labeling function on core teams and coordinate with project teams to determine project and document requirements
  • Has regular contacts with subject matter experts or partners to gather data and understand scope, requirements, risk mitigations, etc.
  • Demonstrate commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA, and other regulatory agencies
  • Keep track of documentation through the entire development process while adhering to timelines, maintaining revision control, maintaining change lists, and managing reviewers
  • Works with internal and external manufacturing partners to support labeling activities
  • Effectively communicates activity status, issues and mitigation plans with stakeholders



  • You have a Master’s degree or related field and five year’s relevant experience ; or equivalent combination of education, training and experience.
  • You have experience serving as the program manager for cross functional project teams in the end-to-end lifecycle
  • An experience operating in regulated design controls environment is a plus
  • You have the ability to lead the development of the labeling process from concept to operation.
  • You have excellent communication skills in English, both written and verbal.
  • You have the ability to establish and maintain effective working relationships with colleagues, managers and suppliers.
  • You are able to learn new concepts quickly and manage multiple projects at once, and are comfortable with changing priorities and schedules.
  • You are able to lead one or more technical evaluations, generate and document test plans and reports.
  • You have a working knowledge of bar code label printing software and printers. You have advanced proficiency in Adobe Illustrator, InDesign, Teklynx/CodeSoft, SharePoint, Prisym, BarTender, SalesForce and QMS/ERP (e.g., IFS).
  • You have a good understanding of computer workflows in ERP software.
  • Knowledge of the documentation process and good documentation practices is preferred.
  • You have sufficient labeling expertise to support technical activities such as performing the labeling approval process.
  • Knowledge of new EU, Canadian, and FDA regulations and guidelines, GMPs, and FDA/EC brand regulatory requirements is a plus.
  • You are able to manage the translation aspect with external agencies.
  • You have excellent attention to detail and high accuracy in word processing
  • You have knowledge of the Microsoft Office suite of products.



You are joining a dynamic & fast-growing environment at the cutting edge of technology and innovation in a global company with great human values, which encourages its teams to take initiatives that contribute to its success.

Profile Group manages this mission in exclusivity. Any interested candidate is therefore invited to apply exclusively through this ad (apply now) or by contacting Profile Group directly. contact: Anaelle Henrard – anaelle – 0470/40.77.30



Placed on:Tue 12 April 2022
Location: Liège


For more information:
at the number: 0470 40 77 30
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