Labeling Sr Specialist
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Labeling Senior Specialist responsible for managing device labeling (including, but not limited to labels, IFUs, Translations, UDI, and labeling systems) as necessary to market Zimmer Biomet products. Advanced understanding and demonstrated leadership of label development, IFU development, change management systems, and global labeling regulations, requirements, procedures and concepts. Demonstrate strong problem-solving skills; analyze all aspects of a situation, challenge current methods, identify potential solutions, and implement the best solution in a timely manner. Solid functional understanding of other departments’ needs, capabilities, and system interfaces. Act as an advisor and mentor to department members and project teams. Strong ability to balance needs of all departments to meet customer expectations and project schedules. Assist in establishing and meeting budget commitments.
Work Location: Bangalore
Work Mode: Hybrid (3 Days in office)
Shift Timing - 11:00 AM - 8:00 PM
How You'll Create Impact
• Serves as the Global Labeling SME for Zimmer Biomet labeling initiatives by working with Regulatory, Development, and other department team members to develop and maintain labeling content and process that complies with labeling regulations (US, EU, OUS as required).
• Leads and manages projects for both company and departmental labeling needs to ensure execution of high quality, efficient labeling; including Acquisitions, Development, Regulatory, UDI, Packaging, Distribution, External Alliance Partners, and Trademark labeling initiatives.
• Lead CAPAs, NCR and complaint investigations and implement Corrective and Preventive actions.
• Serves as a mentor for Global labeling personnel and project team members, providing labeling support, training, and problem-solving assistance.
• Update Global and site level procedures and support other QMS related activities including Standards assessments.
What Makes You Stand Out
- Demonstration of strong problem-solving skills; able to analyze all aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
- Strong ability to build and strengthen relationships with other areas of the organization (i.e. Marketing, Packaging, Development, IT) and other Business Sites.
- Good understanding of how labeling systems communicate with other business systems.
- Ability to create project plan and drive projects.
- Exceptional attention to detail, organization, and multi-tasking skills.
- Commitment to learn and stay abreast of medical devices regulations.
- Understand the overall business environment, the orthopedic industry, and the marketplace
Your Background
- Bachelor’s degree in Science or Technical field with 4+ years’ experience in a labeling or relevant capacity.
- Associate degree in Science or Technical field with 6+ years’ experience in a labeling or relevant capacity.
- High School diploma or equivalent required with 8+ years of experience in a labeling or relevant capacity.
- Lead CAPAs, NCR and complaint investigations and implement Corrective and Preventive actions.
- Experience in Labeling , supporting creation, review, and maintenance of product Labeling across the lifecycle
- Regulatory requirements and standards applicable to Labeling (e.g., FDA, EU MDR/IVDR,UDI and market-specific regulations)ISO 15223, ISO 20417
- US and EU Labeling
- Clear and confident communication skills to discuss Labeling decisions, clarify requirements, and provide inputs during cross-functional reviews
Travel Expectations
Up to 10%
EOE/M/F/Vet/Disability