Responsibilities: Provide management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes. Responsible for Company’s Worldwide Regulatory Compliance, filings, and obtaining the required regulatory approvals to market the Company’s products Assist in Clinical Studies required for Regulatory Approval, including clinical study design, data analysis, and data reduction. Responsible for regulatory strategy for new products and claims. Responsible for keeping management team informed of regulatory status of products and significant regulatory issues. Represent the Company before regulatory authorities Provide counsel, training, and interpretation of FDA and other regulatory issues to Company personnel and assist as a liaison between the Company and regulatory authorities. Responsible for the review and approval of promotional, advertising, and labeling items. Assist in the Compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive, and other regulatory agencies Requirements: Minimum of 5 years managerial experience of Regulatory Affairs/Quality Assurance Activities Experienced in cGMP requirements and preferably ISO-9000 requirements Experienced in regulatory filings Experienced in setting-up and maintaining documentation systems Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration Good conceptual, analytical, problem solving, and organizational skills A “hands-on” individual who enjoys challenge, is capable and dedicated to getting the job done with minimal support and direction An assertive, take-charge, proven manager with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with outstanding administrative capabilities to build, motivate and manage a strong quality organization Well-organized and accustomed to maintaining excellent records Minimum Education: Bachelors degree, preferably in life sciences, engineering, or business