Kappa Search | Chicago Employment Agency | Director Regulatory Affair

Kappa Search Inc., a Chicago employment agency specializing in the recruitment and placement of engineers, technical, manufacturing and supply chain professionals, is currently recruiting for a Director of Regulatory Affairs for a client in the medical electronics industry.

The Director of Regulatory Affairs will provide direction and leadership to Regulatory Affairs Specialists in the development and implementation of regulatory strategies and processes to assure timely commercialization of products in compliance with applicable regulations and standards.

Position Responsibilities

• Provide management and leadership to the Regulatory Affairs organization in such areas as personnel, objectives, projects and responsibilities.
• Contribute to the development and implementation of business unit strategic and operating plan.
• Provide work direction, training and regulatory advice to direct reports and other members of the regulatory department.
• Interview and hire staff as necessary. Review personnel decisions to ensure compliance with overall department goals.
• Review submissions of less experienced regulatory staff and coach as necessary to ensure continuing development of regulatory skills.
• Keep C-level management informed of regulatory status of products and significant regulatory issues, and educate them about new developments.
• Direct submission negotiations with FDA as needed including pre-submission identification of requirements and strategy and post-submission negotiations to ensure timely approval.
• Maintain current knowledge of global regulations pertaining to legal distribution of medical products.
• Conduct annual performance reviews. Assist with setting of objectives and professional development of staff.
• Provide continuing regulatory education and dissemination of regulatory information to the development, marketing and clinical groups.
• Oversee a portion of the department budget; approve spending within defined limits.

Basic Qualifications

• Bachelor’s Degree
• 10+ years of RA industry experience including clinical studies and quality systems management
• At least 4+ years Regulatory experience with Class III Devices