Senior Labelling Engineer

Senior Labelling Engineer


​Our client an Irish Medical device company currently seeking a Senior Labelling Engineer Reporting to the Manufacturing Engineering Manager the Senior Labelling Engineer will become the subject matter expert in unique device identification and label design to support strategic growth plans. The successful candidate will lead the implementation of global UDI initiatives, support product registration and re-registrations in geographical regions, and address necessary changes to meet regional regulatory and OEM customer requirements. Close collaboration with cross-functional teams including Commercial, Regulatory, Supply Chain, and external consultants will be vital to successfully carry out this role.
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Role/Responsibilities

• Act as subject matter expert (SME) on the interpretation and implementation of international regulatory standards including and not limited to ISO 15223-1, ISO 20417, ISO 7010, FDA 21 CFR Part 801, EU MDR 2017/745 and GS1.
• Participate across a diverse range of project teams as SME to support all label and UDI decision-making.
• Lead and oversee projects for the implementation of global Unique Device Identification (UDI) in compliance with regional requirements and medical device regulations.
• Coordinate the gathering and loading of UDI data into various UDI Databases, including GUDID and EUDAMED.
• Manage internal records pertaining to UDI information.
• Design product labels that adhere to regional requirements and medical device regulations.
• Review and verify internally printed artworks and externally sourced labels and documentation to ensure compliance with UDI requirements according to EU MDR regulations, FDA guidelines, GS1 Standards, and Standard Operating Procedures (SOPs).
• Review Customer Agreements concerning UDI data and labelling responsibilities.
• Create and update work instructions and procedures governing UDI and labelling processes.
• Collaborate with suppliers and generate purchase orders for outsourced labelling and translation services.
• Generate product Bills of Materials and Packaging Configuration Instructions.
• As SME present relevant information and defend decision-making in regulatory audits.
• As SME and working with the Regulatory function stay up to date with all labelling and UDI international standards, participate on standards working groups and maintain governing documents in line with standards.
  
  Skills/Experience

• Level 8 Degree qualification in Engineering, Technology, Regulatory or Science with a minimum of 8 years of relevant experience.
• Subject matter expertise on the following standards:
  • ISO 15223-1
  • ISO 20417
  • FDA 21 CFR Part 801
  • ISO 7010
  • GS1 Standards
  • EU MDR 2017/745
• Ability to communicate and operate effectively within cross-functional teams.
  • Proficiency with labelling applications such as Bartender is an advantage.
  • Ability to effectively work within a team to expedite the completion of critical project tasks.
  • Excellent interpersonal skills with demonstrated decision-making competencies.
  • Strong project management and communication skills.
  • Methodical approach to problem-solving with good collaboration and influencing skills.
  • Ability to work on your own initiative, prioritize work and manage several projects simultaneously.
  • Professional experience in writing technical documentation is an advantage.