Director Of Regulatory Affairs

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations. Reporting to the VP of Clinical Quality and...

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...

The Director of Regulatory Affairs leads the global regulatory strategy of the MedTech AI Division, ensuring that all software and hardware products (SaMD, AI-enabled real-time systems, edge–cloud devices, imaging platforms, connectivity and data solutions) comply with U.S., EU, and international regulations.Reporting to the VP of Clinical Quality and...

A leading MedTech firm in Italy seeks a Director of Regulatory Affairs to lead global regulatory strategy.This role oversees compliance of software and hardware products, prepares submissions, and manages regulatory activities with a focus on AI-enabled devices.The ideal candidate has 8-10 years in Regulatory Affairs, including SaMD experience, and at least...

Medical Device – Regulatory Affairs Director ResponsibilitiesLine management of 10 Regulatory Line ManagersEstablish and implement regulatory strategies ensuring new and existing products comply with the latest global requirementsTrain the team on EMEA / FDA requirementsQualificationsMinimum 8 years in regulatory affairs in the medical device...

We're currently partnering with a leadingglobal consumer health businessto find an experiencedGlobal Regulatory Operations Medicine Managerto join their dynamic Regulatory Affairs team.This is an exciting opportunity to lead end-to-end regulatory operations across a diverse portfolio of over-the-counter (OTC) and consumer health products.You'll be working at...

Regulatory Affairs – ResponsibilitiesSupport preparation, update and management of regulatory documentation (dossier, changes, submissions).Collaborate with Quality, Production and R&D to guarantee products comply with regulatory requirements.Monitor national and European regulatory updates (AIFA, EMA).Manage and archive technical documentation according...

Jefferson Wells, per conto di un'importante azienda farmaceutica, è alla ricerca di un Global Regulatory Affairs Specialist.SCOPO DEL RUOLO :Responsible for supporting global regulatory submissions and maintaining compliance with regulatory requirements for pharmaceutical products across multiple regions aligned with global regulatory strategies, with...