Regulatory Affairs Innovator – IVD & Medical Devices

Waters is seeking a Regulatory Affairs Specialist (Innovation) to guide new product development projects for in vitro diagnostics, automated laboratory systems, and related software. You will prepare FDA submissions (Pre-IDEs, PMA, 510(k), De Novo), and EU IVDR documentation, while collaborating with scientists, engineers, clinicians, and business leaders to navigate complex regulatory pathways. The ideal candidate has 2–5 years in regulated healthcare regulatory roles, strong analytical skills,