Crosstex International is a leading global manufacturer of infection control and prevention products for the healthcare market. We create high quality, innovative products, the majority of which are manufactured in the United States. Our broad range of products for multiple healthcare disciplines include: SecureFit® Face Masks, ConFirm® Sterilization Monitoring, SaniTyze™ Waterless Antimicrobial Gel and our Patients Choice ® line of preventive products. With eleven manufacturing/distribution facilities around the world – 7 in the United States and 3 internationally – Crosstex services the global healthcare community in an efficient and timely manner. www.crosstex.com
Degree in a scientific, engineering or related technical discipline with 7-8 years of experience with increasing responsibly within the regulatory affairs/compliance discipline in the life sciences industry. Advanced degree and/or professional certification in regulatory affairs strongly preferred. Demonstrated history of successful regulatory leadership to support business objectives. Developed knowledge of US regulations in the areas of the FDA and EPA and international regulations such as ISO 13485 and EU medical device CE-marking. Management experience in regulated industry required. Proof of strong written and verbal communication skills, especially when dealing with governmental agencies. Ability to explain and resolve differences in regulations. Demonstrated experience in development and execution of regulatory strategy. Experience in planning and preparing FDA, EPA and international regulatory submissions is required.