Director, Global Regulatory Affairs

Summary:

The Director of Global Regulatory Affairs supports the Diagnostics Business unit of PerkinElmer. The role is critical in ensuring all products and services are marketed in compliance with the applicable regulatory regulations worldwide. The role is responsible to setting regulatory strategy for new and modified products, implementing and updating internal processes in response to changing regulations and working to influence authorities in the establishing of new regulations. He/she will possess the ability to manage a large and geographical diverse team (> 20), maintain oversight of multiple parallel registration projects, establish and regularly report on function budget, and execute all responsibilities on time and within budget. Position reports to the Vice President of Global Regulatory, Quality, Medical and Scientific Affairs.

Key Responsibilities:

• Develop registration strategies to support introduction or extension of new and existing products.
• Oversee the execution of strategies to ensure the timely and cost efficient of product registrations and market adoption.
• Ensure all registration activities comply with applicable government and local regulations.
• Collaborate cross-functionally to ensure regulatory requirements are incorporated into project plans.
• Ensure regulatory considerations are evaluated and addressed during change control process.
• Develop policies, programs and procedures for regulatory affairs.
• Prepare, submit and secure FDA registrations, including maintenance of establishment registrations, medical device listings and PMA annual reports and supplements.
• Provide regular reporting to management on registration metrics and department activities.
• Primary interface with FDA on submissions and meetings.
• Provide review and approval of product labeling and promotional materials.
• Responsible for cost center and financial management to annual operating plan and budget