Regulatory Affairs 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.

Responsible for leading medical device labeling projects throughout the product lifecycle and ensuring compliance with global labeling regulations as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of medical device labeling regulation.

• Collaborates with cross-functional departments to create, revise and maintain labeling content that complies with global labeling regulations and requirements, including, but not limited to, Instructions for Use (IFU), information supplied to patients and medical professionals and product labels
• Provides regulatory guidance on labeling requirements to cross-functional project teams to support overall regulatory strategy
• Proposes and evaluates risk of regulatory labeling strategies
• Collaborates with cross-functional teams to gather input, conduct reviews and approvals, and ensure accuracy and consistency in labeling content
• Reviews and evaluates promotional and advertising material for compliance with applicable regulations
• Ensures all labeling changes are documented and submitted in accordance with regulatory andquality management system requirements
• Supports and reviews proposed product labeling changes for impact on regulatory status of theproduct
• Communicates with regulatory and governmental agencies with supervision
• Supports Quality Management System activities to ensure compliance of product labeling such as audits, standards assessment and review, CAPA and complaint investigation
• Stays up-to-date with global regulatory requirements and guidance for medical device labeling
• Provides training and guidance to other departments on labeling processes and regulatory requirements

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

• Strong writing, communication, and interpersonal skills
• Strong attention to detail; ability to multi-task and balance competing priorities
• Knowledge of overall business environment, the orthopedic industry, and the marketplace
• Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
• Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
• Knowledge of FDA, EU, UDI, eLabeling and other regulatory body labeling regulations
• Ability to identify risk in Regulatory labeling strategies
• Strong problem solving skills
• Basic computer skills, including Microsoft Office Suite

• High school diploma or equivalent with 6+ years' experience in Regulatory Affairs, Labeling or relevant capacity
• Bachelor's degree (or non-US equivalent) with concentration in life sciences, technical/engineering or related field preferred
• Previous experience in orthopedic or medical device industry preferred
• A minimum of 3 years of experience in Regulatory Affairs, Labeling, Engineering, Quality, or related field required

Up to 10%

EOE/M/F/Vet/Disability