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
Are you looking for a career that makes a difference in people’s lives? We are expanding our team and encourage you to consider a career at Balt. We pride ourselves on our patient-focused mindset and dedication, which allow us to work closely with colleagues, share knowledge, and strive to reimagine medicine. As a team member of Balt, you will have an impact on the continued evolution of Balt: from its history as a niche R&D company in Europe to a global neurovascular device company.
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.
You are responsible for (but not limited to):
- Directly manages the labeling team. Provides coaching, mentoring, and effective oversight of the team.
- Identify and leverage opportunities to drive improved label process (e.g., culture, training, processes, tools, standards, etc.).
- Leads and ensures cross-functional collaboration to comply with labeling procedures and external global regulatory standards in an effective and efficient manner.
- Sets expectations of key suppliers related to printed labels, translations, and IFU printing.
- 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.
- 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.
- Identifying and communicating quality or compliance risks associated with product labeling and determination of appropriate plan to address risks.
- Participating and/or overseeing the disposition of product labeling and finished good
- Responsible for labeling design reviews as needed.
To Succeed in this role, you should have the following skills and qualifications:
- Attention to detail, document management, and strong project management skills.
- 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.
- Demonstrated ability to work effectively and build cross-functional relationships with internal and external personnel.
- Strong analytical thinking, questioning & problem-solving skills.
- Microsoft Word, Excel, PowerPoint, and Outlook.
- Minimum 5 years’ experience with developing artwork and graphics for FDA regulated medical device or drug products. Creation and management of labeling design changes.
- Minimum 3 years’ experience in a managerial role with direct reports.
- Knowledge and understanding of FDA and ISO medical device labeling regulations.
- Experience utilizing label design software such as Easy Label, NiceLabel, Bartender, or Adobe Illustrator/Photoshop and other related software
- Education: Bachelor’s degree in a technical or business management area.
BALT is a world leader in the design and manufacture of interventional neuroradiology devices to treat neurovascular pathologies (strokes, aneurysms, AVMs). By placing innovation at the center of its model, the company maintains its leading position in the neuroradiology field worldwide. We are growing our company worldwide with a focus on the commercialization of Balt products in the United States as well as continuing a tradition of physician inspired innovation through novel research and development.
Diverse workforces create the best culture, company, and products! We at Balt are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Balt does not discriminate based on sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Purchasing Clerk / Planner
Responsible for researching and negotiating with suppliers to obtain favorable pricing and specifications in supporting Manufacturing and R&D needs. Prepares purchase orders and maintains records, working closing with Manufacturing and Accounting on budget and data accuracy.
1. Provide support to Manufacturing and R&D Departments for researching and negotiating for prices and specifications for supplies as required
2. Prepares Purchase Orders and maintains purchasing records
3. Works closely with Controller and Accounting Department to ensure budget and data accuracy are maintained
1. Ability to effectively articulate and communicate with management, employees and suppliers
2. Efficient and accurate processing of Purchase Orders
3. Strong planning and organizational skills and records retention
4. Proficient computer skills and typist
5. Good general math skills
1. Direct experience in Purchasing role
2. Demonstrated ability to research and negotiate; supplier interface
3. Ability to handle multiple tasks and meet deadlines