Regulatory Labeling Specialist Jobs

Department: Regulatory

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: Senior Director Regulatory Compliance and Remediation

Description

This office 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 Exactech Inc. 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.

Key Responsibilities

• Initiate change requests for new and revised labeling, work with Labeling team to create, maintain, and implement compliant labeling, review product labeling against indicated content, and approve/release labeling.
• Understanding of the orthopedic industry, and the marketplace.
• Serve as company-wide labeling SME working with various workstreams to maintain compliant labeling needs.
• 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 deliverables.
• Demonstration of strong problem-solving skills; able to analyze all variables in a situation, identify potential solutions, and implement the best solution in a timely manner.
• Work with Regulatory, Engineering and Development, Packaging, and other departments to develop/create labeling and labeling templates that complies with worldwide regulations and requirements using existing software.
• Serve as the Global Labeling core team member for Exactech Inc. labeling initiatives, including but not limited to NPD (new product development), maintenance projects, and UDI tasks.
• Good understanding of how labeling systems communicate with other business systems
• Commitment to learn and stay abreast of global medical devices regulatory requirements.

Skills, Knowledge & Expertise

Education:

• High School Diploma or GED required. Associate and/or Bachelor's Degree from an accredited institution preferred

Experience:

• Experience with regulatory documentation is preferred
• Minimum 7 years' experience in related work experience
• Functional/Technical Knowledge, Skills and Abilities
• Familiarity with graphical software is preferred

Required:

• Ability to work in team environment
• Excellent communication and interpersonal skills
• Proficient in use of Microsoft Office suite and other computer applications