Associate Director, Regulatory Affairs - Digital Health, Device & Combination Products (all gender)

Job description

Take on the role of an Associate Director, Regulatory Affairs – Digital Health, Device & Combination Products. Lead global regulatory strategy for innovative drug-device combination products, collaborating with cross-functional teams to ensure compliance and timely approvals. Shape the future of healthcare with your expertise in regulatory submissions and stakeholder engagement. Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to... Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to en... drug-device combination product regulatory strategy, cgmp for combination products, us fda regulatory submissions

(ind, nda, bla, 510(k), pma), technical file compilation, eu medical device regulation (eu-mdr), quality management systems (qms), iso 13485 / mdsap, eu marketing authorization application (maa / nbop / cta), ectd submissions, ich guidelines, regulatory cmc (chemistry, manufacturing and controls)