IVD Quality & Regulatory Lead – Global Compliance

Software Placement Group is seeking a hands-on Quality and Regulatory Manager to lead QA/RA for IVD products, overseeing QMS, regulatory submissions, and audits across manufacturing, R&D, and commercial activities. The role requires a Bachelor's in life sciences or related field and 5+ years of QA/RA experience, with strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR/IVDD, and proven track record in regulatory submissions, CAPA, and process validation.