Regulatory Affairs Specialist (Innovation)

Skip to main contentWe use cookies and other tracking technologies to assist with navigation, improve our products and services, assist with our marketing efforts, and provide content from third parties. By continuing to use this site you agree to our use of cookies in accordance with our privacy policy. Manage third-party cookie preferences hereDeclineAccept CookiesEnglishSign InRegulatory Affairs Specialist (Innovation) page is loadedRegulatory Affairs Specialist (Innovation)Applyremote typeIn-OfficelocationsUSA MD - Sparks - 7 Loveton Circletime typeFull timeposted onPosted 30+ Days Agojob requisition idR-547486As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purposeBD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Job DescriptionThe Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for in vitro diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.Responsibilities:Serves as Regulatory Affairs SME on various new product development (NPD) teamsWorks cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functionsRecognizes and addresses potential regulatory risks with project plansResponsible for organizing and leading various FDA & EU IVDR submissionsServes as contact to FDA and Notified Body review teams during submission reviews/communicationRecognizes and proposes continuous process improvements.Required Education and Experience:Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)Minimum 5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s)Preferred Skills and Experience:RAPS Certification preferredDemonstrated experience in interpreting subjective and complex aspects of specific regulationsDemonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processesDemonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid changeDemonstrated success in...