04 ago
|
F. Hoffmann-La Roche
|
San Cugat del Vallés
04 ago
F. Hoffmann-La Roche
San Cugat del Vallés
ph3Company Culture /h3pAt Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. We aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. /ph3Position Overview /h3pThe Position At Roche, we believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are brave in both decision and action. And we believe that good business means a better world. Join Our Team: Make a Difference in International Regulatory Affairs! /ppRoche is seeking a dynamic and highly motivated individual to join our team as an International Regulatory Affairs Professional. We are looking for candidates who bring an innovative and creative mindset to the table, along with a proven track record in the Regulatory Affairs field. If you are passionate about making a positive impact on integral healthcare through regulatory excellence, we invite you to be part of our dedicated team.
/ph3Key Responsibilities /h3ulliLeading and supporting regulatory strategies for global IVD/MD instruments and software submissions /liliEnsuring compliance with international regulatory requirements and standards /liliCollaborating with cross-functional teams, including RD, Quality, and Clinical, to drive regulatory initiatives /liliProviding regulatory guidance to support product development and lifecycle management /liliStaying abreast of evolving regulatory trends and updates, and implementing best practices /li /ulh3Requirements /h3ulliBachelor’s Degree in Life Sciences, Regulatory Affairs, or a related field /lili5 to 7 years of experience in Regulatory Affairs (Regulatory, RD, Quality and/or Clinical), with some experience in healthcare regulatory affairs /liliIn-depth knowledge of global regulatory requirements, guidelines, and procedures especially for IVD instruments software /liliStrong organizational and communication skills /liliAbility to multitask and effectively manage multiple projects simultaneously /liliSelf‑motivated and capable of working independently in a self‑management environment /liliExperience in IVD instrument and/or software development /li /ulh3Benefits /h3ulliCollaborative and innovative work environment /liliOpportunity to make a meaningful impact on patients' lives globally /liliCompetitive compensation and benefits package /liliProfessional development and growth opportunities within a leading global healthcare organization /li /ulpRoche is an Equal Opportunity Employer. /p /p #J-18808-Ljbffr
📌 Regulatory Affairs Manager (San Cugat del Vallés)
🏢 F. Hoffmann-La Roche
📍 San Cugat del Vallés