Senior Manager, Regulatory Affairs
Sysmex America, Inc | |||||||||
United States, Illinois, Lincolnshire | |||||||||
577 West Aptakisic Road (Show on map) | |||||||||
May 11, 2024 | |||||||||
Senior Manager, Regulatory Affairs Job Location(s)
US-IL-Lincolnshire
Overview Find a Better Way... ...to use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way. ...to improve the lives of others. Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory. ...to build a promising future. Responsibilities We currently have a great opportunity available for a Regulatory Affairs Senior Manager. The Senior Manager position in Regulatory Affairs leads the regulatory strategy for new and modified Sysmex medical device products. The individual will lead, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities in the US & Canada. The Senior Manager Regulatory Affairs is the regulatory expert and is responsible for leading the preparation, documentation and submission of regulatory applications for Sysmex products. The Sr Manager Regulatory Affairs will have the opportunity to manage RA team members and will report to the Sr. Director, Regulatory Affairs. Essential Duties and Responsibilities: 1. Leads preparation, documentation and submission of FDA and Health Canada applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance. Ensure understanding of risk and approximate timing for approvals for planning purposes 6. Maintain current knowledge of relevant regulations and guidelines both proposed and final rules including those for IVD products. Percentage of Travel: Minimal 5-10% Qualifications * Bachelor's degree in science related field or equivalent required. Minimum 7+ years of progressive experience in medical devices/IVD/biotech industry Regulatory Affairs required, including experience in Armed Forces. * RAC would be a plus Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job. Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing. |