...designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator... ...required to manage the preparation of local clin...
About the Role
Location: Barcelona, Spain (Hybrid)
In this global role as Vigilance Process Manager, you will be responsible for the end-to-end management of assigned pharmaco- and devices vigilance processes across Nov...
...pharmacovigilance service provider initially established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services wit...
...position will be located in Madrid and it´s for our Cardiac Rhithm Management (CRM) division. Our business purpose is keeping your heart... ...with medical technologies that help you and your...
...We are looking for a Regulatory Affairs Manager- Medical Devices with experience within the medecth and/or pharmaceutical industries and team management to join us, someone who loves to take on new challenges, to wo...
...service, study acceleration, and high-quality data collection.
Driving principles and behaviors for this role are collaboration, accountability, innovation, adaptability, integrity and caring.
Through coordina...
...submissions (renewals, annual reports, change notifications, memos to file, etc.) to maintain market access in the target markets/regions (e.g., maintains Technical Files and associated documentation for European Un...
...dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: ukh301 | regulatory affairs Escribe tu dirección de correo electrónico, te permitirá de estar al tanto de los últimos empleos por: ukh301 | reg...
...the requirements.
Perform design failure mode and effect analysis (DFMEA) on designs
Apply applicable standards and guidelines (e.g., IEC60601, ISO14971).
Create test plans to verify our electronics and emb...
...functions on regulatory requirements and assigned business processes.
Acting as a subject matter expert during audits and inspections (e.g. FDA and EMA), leading the preparation of responses to findings and the d...
