Senior Regulatory Manager (Labeling)

Senior Regulatory Manager (Labeling)

Department: Regulatory

Employment Type: Full Time

Location: Gainesville, FL

Reporting To: VP of Regulatory and Clinical Affairs

Description

The purpose of the Senior Manager Regulatory Affairs - Labeling is to provide leadership for the Regulatory Labeling Department to fulfill the Labeling requirements necessary to achieve global regulatory approvals or licenses and maintain overall regulatory compliance for the company.

Key Responsibilities

• Direct the work of others in preparing and maintaining regulatory labeling requirements to support pre-market submissions and license applications for New Product launches, design changes, and new market launches, including but not limited to FDA submissions, European Union Technical Files, Canadian device license applications, and other markets.
• Direct the work of others in creating, compiling, and maintaining draft and final labels to support technical file and regulatory dossier documentation for CE marking, licensing, and registrations.
• Advise product development teams and management on changing labeling requirements globally and the impact of those changes on current and planned regulatory clearances/licenses.
• Interface with distributors, sales force, international representatives and the Engineering and Development teams for labeling strategy development for market entry.
• Act as the designated Exactech contact with translation vendors and other contract labeling vendors to support device licensing/registration and product distribution.
• Provide regulatory review, guidance, and strategy for international and promotional labeling.
• Provide training to employees, sales agents, sales representatives and customers regarding international regulatory requirements for labeling.
• Lead or participate in Regulatory and QMS audits (internal or external) to achieve successful audit outcomes.
• Ensure that company procedures processes and documentation meet the required guidelines for maintaining compliance to domestic and international regulatory requirements and standards for device labeling. Lead process improvement efforts to support Exactech's Best in Class quality goals.
• Provide knowledge and support to the company's different business units to enable operation within company and regulatory guidelines.
• Actively participate in regulatory industry groups (e.g., OSMA, AdvaMed, ASTM) to: a. Ensure Exactech remains current and informed in an evolving global regulatory environment b. Provide a forum for Exactech to have a role in influencing change.
• Assist in supporting other employees, teams, and sales personnel as necessary.
• Practice Exactech's Values.
• Know and apply the Quality System and any appropriate Federal and International standards

Skills, Knowledge & Expertise

Education:

• Bachelor's Degree in a related field from an accredited institution required; Master's Degree preferred

Experience:

• Minimum 7 years' experience in FDA/ISO and international medical device labeling and quality management system standards required
• Minimum 5 years' experience supervising or managing a team

Functional/Technical Knowledge, Skills and Abilities Required:

• Technical writing skills required
• Experience in Label Design, Labeling Requirements, and Design Controls
• Working knowledge of windows based office productivity tools including word processor and spreadsheet