Regulatory Affairs Consultant: Medical Device IVDR

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7l8phq

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal
Se le sue competenze, la sua esperienza e le sue qualifiche corrispondono a quelle descritte in questa panoramica, non ritardi l'invio della sua candidatura.
- to improve the world's health.
From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special
- a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will vantaggi a patient.
We take our work personally, we do it with empathy and we're committed to making a difference. About the RoleWe are seeking an experienced Regulatory Affairs professional to lead IVD (in vitro diagnostic devices) regulatory strategy.
In this pivotal role, you will provide expert guidance on regulatory pathways for performance evaluation studies and marketing authorizations, and serve as the key regulatory representative for our global project teams.



The role can be home or office based in various European locations. Key ResponsibilitiesDevelop comprehensive regulatory strategies for performance evaluation studies.
Support the preparation of technical documentation of IVDs products.
Represent the regulatory affairs function in global project teams and governance meetings.
Lead regulatory interactions with health authorities and notified bodies, including preparation of documentation and coordination of meetings.
Manage regulatory activities throughout the IVD clinical development lifecycle and marketing authorization.
Maintain global regulatory databases with accurate and current information.
Coordinate with cross-functional teams to ensure timely and compliant regulatory submissions.
Contribute to continuous improvement initiatives, innovation, and strategic planning within the regulatory function.
Skills and Experience: University degree in a scientific discipline, tec

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7l8phq