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You will be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
This Expert Level role provides on‑site regulatory leadership with a strong manufacturing focus, ensuring regulatory considerations are embedded early into site initiatives and day‑to‑day operations. This leader interacts closely with global and
Accountable for assessing, establishing and operationalizing the regulatory strategy and execution plan for assigned IVD performance studies and for clinical trials that use IVDs, ensuring that study conduct and IVD use are compliant with the EU IVDR
You will be responsible for defining and implementing the regulatory pathway, from early strategy through to dossier submission, working closely with CMC, Clinical, Medical, and Quality teams. Define and implement the global registration strategy (Main