Labeling Specialist

Location: Bengaluru

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

The person in this position is responsible for leading medical device labeling projects (including, but not limited to product labels, IFUs, translations, labeling systems, and UDI initiatives) as necessary to market Zimmer Biomet products. It requires demonstrated leadership and communication skills, as well as a broad understanding of label and IFU development, change management systems/procedures/concepts, and labeling systems. This position must have the ability to work effectively and efficiently with all Zimmer Biomet team members, have a good understanding of global labeling regulations and requirements, and have the ability to generate creative labeling solutions as new labeling requirements unfold.

Strong attention to detail, written and oral communication, teamwork, and organizational skills are essential, as well as an understanding of Zimmer Biomet products and their use.

Work Location:

Bangalore

Work Mode:
Hybrid (3 Days in office)

How You'll Create Impact

Serve as the Global Labeling core team member for Zimmer Biomet labeling initiatives, including but not limited to NPD (new product development), CPI (Core product improvement), , PMI/custom products, and UDI tasks
Work with Regulatory, Development, Brand, Packaging Development, Manufacturing and Other departments to develop/create labeling that complies with US, EU, and UDI labeling regulations and requirements, as required.
Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
Coordinate services and works effectively with vendors and suppliers of services (e.g., translation vendors, print vendors, instrument and/or implant suppliers) to ensure execution of high-quality deliverable.
Complete Destination labeling, eLabeling for all labeling documents such as but not limited to IFU, Surgical Technique, Creating Material specification and formats for printed IFU
Lead CAPAs, NCR and complaint investigations and implement Corrective and Preventive actions.

What Makes You Stand Out

Broad knowledge and understanding of US, EU, and UDI labeling regulations, as well as overall FDA and MDD/MDR regulations preferred.
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.
Exceptional attention to detail, organization, and multi-tasking skills.
Understand the overall business environment, the orthopedic industry, and the marketplace.

Your Background

Required Skills

Prior hands-on labeling experience, supporting creation, review, and maintenance of product labeling across the lifecycle.
Working familiarity with regulatory requirements and standards applicable to labeling (e.g., FDA, EU MDR/IVDR,UDI and market-specific regulations).
Ensures compliant labeling creation, accurate data loaded to labeling systems, approval, maintenance, and label release, including appropriate procedures, work instructions, and forms.
Clear and confident communication skills to discuss labeling decisions, clarify requirements, and provide inputs during cross-functional reviews.
High attention to detail and ability to follow structured processes and documentation standards with affinity to big data management and data processing knowledge.

Education And Experience Requirements

Bachelor's degree in Science or Technical field with 2+ years' experience in a labeling or relevant capacity.
Associate degree in Science or Technical field with 4+ years' experience in a labeling or relevant capacity.
High School diploma or equivalent required with 6+ years of experience in a labeling or relevant capacity.

Travel Expectations

Up to 5%

EOE/M/F/Vet/Disability