Are you inspired by a fast-paced, innovative environment that will challenge you to find creative solutions? At Balt, we foster a culture of collaboration that drives constant innovation. Our goal is to enhance the care of patients with neurovascular disease through physician-inspired innovative solutions. Balt’s 40 year legacy of bringing first-to-market products is now in the US. We are looking for dedicated, creative and collaborative individuals to join us in building the next great neurovascular device company. If this sounds like you, please select from our open positions below.

Global Labeling Manager

The Global Labeling Manager is responsible for planning, organizing, developing, and implementation of all activities within the labeling function. This role will also support all labeling for current commercialized products and new product development. The individual in this role will identify opportunities for new labeling concepts, materials, process, and systems.

1.       Directly manages the labeling team. Provides coaching, mentoring, and effective oversight of the team.

2.      Identify and leverage opportunities to drive improved label process (e.g., culture, training, processes, tools, standards, etc.).

3.      Leads and ensures cross-functional collaboration to comply with labeling procedures and external global regulatory standards in an effective and efficient manner.

4.      Sets expectations of key suppliers related to printed labels, translations, and IFU printing.

5.      Manages the end-to-end labeling process to minimize the risk to patients of a significant error occurring in final labeling preparations that results in a product delay or recall due to labeling.

6.      Development of SOPs (Standard Operating Procedures) for Labeling, UDI and EUDAMED in compliance with the internal and key external global regulatory requirements including EU MDR.

7.      Identifying and communicating quality or compliance risks associated with product labeling and determination of appropriate plan to address risks.

8.      Participating and/or overseeing the disposition of product labeling and finished goods

9.      Responsible for labeling design reviews as needed

Qualification Requirements

  1. Attention to detail, document management, and strong project management skills.
  2. Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
  3. Demonstrated ability to work effectively and build cross-functional relationships with internal and external personnel.
  4. Strong analytical thinking, questioning & problem-solving skills.
  5. Microsoft Word, Excel, PowerPoint, and Outlook

Pre-requisites/Job Experience

1.       Minimum 5 years’ experience with developing artwork and graphics for FDA regulated medical device or drug products. Creation and management of labeling design changes.

2.      Minimum 3 years’ experience in a managerial role with direct reports.

3.      Knowledge and understanding of FDA and ISO medical device labeling regulations.

4.      Experience utilizing label design software such as Easy Label, NiceLabel, Bartender, or Adobe Illustrator/Photoshop and other related software

5.      Education: Bachelor’s degree in a technical or business management area

Sr. Labeling Specialist

The Labeling Specialist is responsible for the overall coordination, development, and execution of labeling for commercialized and new product development products.

1.      Design, develop and update global labeling documents to include product labels, instructions for use (IFUs), implant cards, and other related labeling materials.

2.      Collaborates with cross-functional team members to ensure the accuracy of all information included on the label or in the labeling.

3.      Manage labeling changes within the approved document management system.

4.      Collaborates with labeling change request initiators to understand requirements, design solutions, timelines, and deliverables.

5.      Develop standardized and optimized label templates.

6.      Supports investigations, root cause analysis and corrective action to address labeling non-conformances.

7.      Coordinate with suppliers and vendors for outsourced printed products and translated materials.

8.      Ensure labeling compliance with quality management system (QMS), regulatory requirements and guidelines, standard operating procedures, and work instructions.

9.      Coordinate training for manufacturing personnel related to label system operation and maintenance.

10.    Contribute to the development and documentation of business processes to support product labeling.

11.    Attention to detail, document management, and strong project management skills.

Qualification Requirements

  1. Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
  2. Ability to read and interpret general product description information and technical procedures.
  3. Microsoft Word, Excel, PowerPoint and Outlook

Pre-requisites/Job Experience

1.      Minimum 3 years of labeling experience in an FDA or EU regulated environment. Medical device or pharmaceutical industry.

2.      Experience utilizing label design software such as Easy Label, NiceLabel, Bartender, or Adobe Illustrator/Photoshop and other related software

3.     Education: Associate level degree