Global Regulatory Affairs Lead – Medical Devices (Remote)

Croma-Pharma; Gemeinde Leobendorf; Presencial; EUR 55.000 - 67.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Flexible working hours

Home office

Public transport connections and free/

Meal allowance

Pension and health care

Professional development

Descripción de la vacante

Croma-Pharma is seeking a Regulatory Affairs Manager for aesthetic medical devices to drive global registrations, including ASEAN and Russia, in a dynamic, international environment. You will plan and implement registrations, assess change notifications, ensure renewals, monitor regulatory requirements within the QMS, and liaise with consultants and distributors to maintain compliant operations.

This role offers flexible hours and strong development opportunities within a growing company based

Formación

• Bachelor’s degree and 3–5 years regulatory affairs experience in medical devices.
• Experience preparing and submitting regulatory dossiers and managing global projects.
• Russian language is a plus.

Responsabilidades

• Manage regulatory projects for aesthetic medical devices on a global scale (ASEAN, Russia).
• Plan and implement medical devices registrations in these areas and ensure maintenance of registrations.
• Assess change notifications and prepare/submit variations for registrations and renewals.
• Oversee regulatory requirements within the quality management system and ensure compliance.
• Communicate with regulatory consultants and distributors.
• Conduct regulatory intelligence and internal trainings.

Conocimientos

Regulatory affairs

Global project management

Dossier submissions

Russian language

Educación

Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or related field

Descripción del empleo

Croma-Pharma is seeking a Regulatory Affairs Manager for aesthetic medical devices to drive global registrations, including ASEAN and Russia, in a dynamic, international environment. You will plan and implement registrations, assess change notifications, ensure renewals, monitor regulatory requirements within the QMS, and liaise with consultants and distributors to maintain compliant operations.

This role offers flexible hours and strong development opportunities within a growing company based