Overview

Manages regulatory affairs communication, filing strategy, regulatory negotiation, submission development, query response development and other assigned activities related to the US, EU, Canada and other regions, as required. Provides expertise in translating regulatory requirements into practical, workable plans. Develops and implements strategies for earliest possible approvals of regulatory applications. Provides counsel to and manages a regulatory team. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, agents, regulatory agencies) as needed to support business objectives.

Responsibilities

• Prepare PMAs, Design Dossiers, or similar submissions/registrations and subsequent amendments/supplements.
• Participate in audits, inspections, as needed. 
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures, labeling, clinical studies, testing and/or record keeping.
• Provide input to leadership and development teams to assure that global regulatory requirements are incorporated as part of the development and/or change control process. 
• Review marketing and promotional materials for compliance with international registrations and requirements.
• Interact with suppliers, vendors, and partners on project-related activities necessary to ensure appropriate regulatory clearances and approvals are in place.
• Communicate with regulators and/or ministry of health officials, as assigned.
• Lead a team of regulatory professionals.
• Perform other duties as assigned by supervisor.

Qualifications

• Managerial and leadership competence to motivate and develop staff.
• Strong interpersonal skills including ability to interact with high degree of diplomacy and to effectively collaborate with project teams and other departments.
• Good project management skills and the ability to appropriately adjust priorities.
• Extensive knowledge of global medical device regulations and product development processes.
• Comprehensive knowledge of quality systems and relationship to business.
• Experience in developing and communicating global regulatory strategies.
• Provide leadership, creativity, and business acumen when interpreting regulatory standards and guidances. 
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
• Able to apply extensive technical or regulatory principles, theories, and concepts and has full knowledge of other related disciplines.
• Able to develop technical solutions to complex problems that require the regular use of ingenuity and creativity. 
• Must be self-motivated, self-disciplined, and able to prioritize/manage/complete multiple tasks and responsibilities within the internal commitment dates.
• Expertise in Microsoft Office applications and charting programs.
• Effective problem-solving techniques
• Excellent applied thinking and technical writing skills