Regulatory Affairs Consultant: Medical Device Ivdr

Overview In this Regulatory Affairs Lead role, you shape IVD regulatory strategies, guiding performance evaluation and marketing authorizations. You will act as the regulatory lead for global project teams, coordinating interactions with authorities and ensuring compliant submissions. The role supports lifecycle management and continuous improvement within...

Sei pronto ad entrare in una realtà internazionale che sta ridefinendo gli standard dell'industria farmaceutica e dei Medical Device? In PQE Group, la nostra divisione Regulatory Affairs è sempre in una fase di grande crescita grazie ad un mercato in continua evoluzione che sempre più richiede la qualità dei nostri servizi. Per questo motivo abbiamo la...

LocationMilan or SalernoSummaryThe Regulatory Affairs Portfolio Manager owns the regulatory strategy and technical file of Newel's medical device software, from classification through to submission and post-market maintenance, and acts as the regulatory partner to internal teams, notified bodies and authorities.Major accountabilitiesDefine device...

Sei pronto ad entrare in una realtà internazionale che sta ridefinendo gli standard dell’industria farmaceutica e dei Medical Device? In PQE Group, la nostra divisione di Regulatory Affairs è sempre in una fase di grande crescita grazie ad un mercato in continua evoluzione che sempre più richiede la qualità dei nostri servizi. Per questo motivo abbiamo...

About MiraMira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000 customers. In 2023, we were recognized by Inc. 5000 as America's fastest-growing femtech company.About MiraMira is a San Francisco-based hormonal health company providing integrative care and hormonal testing for over 300,000...

SGS is seeking a QA professional to maintain the NB 1639 medical device internal quality management system and handle daily QA tasks in line with MDD, MDR and IVDR requirements.The role reports to the Quality & Regulatory Manager, Business Assurance. It is remote-based, open to candidates across Europe with valid work permits, and requires a Biomedical...

Johnson & Johnson is seeking a Senior Regulatory Affairs Specialist, Italy, to manage regulatory planning, execution, and compliance across Electrophysiology and Neurovascular businesses.Consulti la panoramica del ruolo qui sotto. Se è sicuro/a di possedere le giuste competenze ed esperienze, si candidi oggi stesso.You will coordinate registrations, support...

Sentinel Diagnostics, leader in the Development and Production of Diagnostic Kits for Clinical Chemistry, Immunology, Molecular Biology, Chromatography and Rapid Tests, in order to expand the RA Team, is looking for a: Senior Regulatory Affairs Specialist FDA & International Registrations Key Responsibilities: Define and implement regulatory...

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...