In this role, you will fill documentation gaps on legacy product families, develop evaluation plans for new product development, assess biological safety impact for sustaining and post-market activities in accordance with ISO 10993-1, manage testing programs with contract labs, and serve as subject matter expert during FDA/notified body interactions. Author and review biological evaluation reports (BERs), toxicological risk assessments (TRAs), and material characterization reports supporting 510(k), PMA, De Novo, and international submissions (CE marking under MDR, etc.).