Endoscopy procedure disposables include single-use valves and irrigation tubing. Medical device reprocessing systems, disinfectants, detergents and other supplies are used to disinfect high-level endoscopes. This segment is operated through MEDIVATORS.
Water purification systems for dialysis facilities, including hemodialysis dialyzer and reprocessing systems, as well as sterilants and filtration products. This segment is operated through Mar Cor Purification, Inc. and MEDIVATORS.
Single-use, infection prevention products used primarily in the dental market including face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants. This segment is operated through Crosstex International, Inc.
Degree in a scientific, engineering or related technical discipline with 3-5 years of experience with increasing technical expertise and 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 MDD/MDR/REACH/BPR. 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.