Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Labelling Specialist

Labelling Specialist
Job Summary:

The Labelling Specialist will provide subject matter expertise on all aspects of label formation, design and configuration and lead the Manufacturing activity for commercialization of exiting products.

Roles Duties/Responsibilities:

  • Lead the design and co-ordination of all labelling activities for New Product Development, legacy labelling, and labelling update projects. This will include product label design DFU’s (Directions for Use) and labelling specification generation
  • Knowledge of Barcoding systems, UDI requirements and GS1 specifications
  • Interface with the Design, Quality Assurance and Regulatory departments to provide labelling input to product submissions
  • Generating design assurance documentation for the project (label specifications, BoM’s, DMR’s, PRTM, Risk documentation) using a high degree of initiative to seek out information for documents
  • Coordinate Product registration activity within the Manufacturing department including translations, label updates and documentation updates through change control
  • Co-ordination of OEM customer request activity that can include label changes and regularity compliance information
  • Oversee compliance to labelling standard changes and regulatory requirements
  • Perform other assigned tasks as directed by Supervisor or Head of Function

Education/Experience:

  • Minimum 4 years’ experience in the Medical Device Industry and / or other regulated industry
  • Level 8 qualification in an Engineering or relevant discipline

Specific Requirements:

  • Excellent understanding of Labelling design requirements
  • Ability to effectively work within a team to expediate completion of critical project tasks
  • Excellent interpersonal skills with demonstrated decision making competencies
  • Very strong organizational, Project Management and communication skills
  • Meticulous attention to detail with a methodical and analytical approach to problem solving
  • Flexibility to travel to vendor sites to support service and project activities
  • Must be able to work in a dynamic environment with little supervision or daily direction
  • Professional experience writing technical documentation an advantage

Environmental Conditions:

  • Typical office environment with work also performed in Manufacturing areas in addition to supplier locations
  • Some national and international travel will be required with role (approx. 5%)

For further information on this Labelling Specialist role in Galway please contact Amanda Reynolds on 0860468858/ technical@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

  Apply with Google   Apply with Twitter
  Apply with Github   Apply with Linkedin   Apply with Indeed
  Stack Overflow
Labelling Specialist

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here