EU Regulatory

Mira, a fast-growing femtech company, seeks a Regulatory Submission Specialist to lead and support regulatory documentation for in vitro diagnostic devices. You will ensure compliance across technical documentation and regulatory programs while collaborating with internal teams and external consultants.The role emphasizes EU IVDR CE-marking readiness,...

Newel Health Srl in Italy is seeking a Regulatory Affairs Manager to oversee regulatory activities for its SaMD portfolio. The role is full-time and on-site in Milan or Salerno, reporting to the head of Regulatory Affairs.You will define product classification and regulatory strategies, coordinate technical files, manage submissions to notified bodies and...

Mira 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. Mira’s breakthrough innovation was creating the market’s only FDA-compliant at-home hormone monitor with quantitative testing technology....

Overview In questa posizione, sei responsabile della gestione regolatoria per mercati extra-UE, assicurando conformità e supportando strategie di sviluppo e commercializzazione. Lavori a stretto contatto con consulenti, partner locali e team interni per avanzare le attività registrative e l’espansione internazionale. Interagisci con autorità e...

Mira, a San Francisco-based hormonal health company, seeks a Regulatory Submission Specialist to lead regulatory documentation for IVD devices. You will ensure evidence supports claims, align labeling, and coordinate with internal teams and external consultants to maintain compliance throughout the product lifecycle.The role requires EU IVDR experience,...

We are looking for a Regulatory Affairs Manager to join our Regulatory Affairs Team. WHAT WILL YOU DEAL WITH? Strategic Regulatory activities: Supporting the definition of global and regional regulatory strategies, identifying optimal registration pathways based on product characteristics, development stage and target markets. Providing strategic guidance...

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Join our team of experts in regulatory and ethics submissions of clinical studies....

Location Milan or Salerno Summary The 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 accountabilities * Define device...

Company Description Newel Health develops certified digital medical devices that extend care beyond traditional clinical settings, with a focus on chronic conditions such as cardiometabolic disease, Parkinson’s disease, and chronic pain. The company designs, develops, and manufactures Software as a Medical Device (SaMD) solutions that integrate artificial...