Quality and Regulatory System Manager (m/f). Luxemburgo

Description de tâches:

Quality and Regulatory System Manager

Your mission:

    Manage the Quality document system

    Participate in the deployment of the Company's Quality policy

    Sustain the Quality approach by maintaining the effectiveness of the Quality Management System in accordance with the requirements of quality standards (ISO 13485/ 9001/MDSAP) and directives/regulatory applicable (PED/TPED/CPR/MDD/MDR).

     Coordination of internal and external audits to ensure the quality of processes.

     Development and updating of regulatory files in accordance with local and international requirements.

     Ensure the processing, management and follow-up of files relating to vigilance and product recalls

Our expectations:

-      Must have:

    Master 1 or 2 in Quality Management, ideally in the health sector.

    You have a good knowledge of ISO 9001 and 13485 standards, the regulatory environment of health and medical devices.

    A first experience of 3 or 5 years in the Healthcare industry would be a plus.

    Knowledge of relevant quality standards and tools (ISO 9001-ISO13485-MDD-MDR-MDSAP).

    Expertise in interpreting and applying industry-specific quality standards and regulations.

    Fluent in regulatory, technical and scientific English.

    At ease with the MS Office suite.

-      Soft skills :

    Work in a multidisciplinary mode, to analyze the stakes of other activities and to advise internally on regulatory aspects.

    Excellent communication skills for collaboration with internal teams and regulatory bodies.

    Ability to work independently and take proactive initiative.

    Results-oriented with meticulous attention to detail.

-      Nice to have :

    A good level of French is a plus

Joining Rotarex, means benefiting from:

    The growth of a major industrial group with a great worldwide reputation

    A family business culture

    Numerous opportunities for professional training, personal development, and internal mobility throughout your career

    The technicality of our jobs, where innovation, invention and inspiration are at the heart of our strategy

    Flexible working hours, allowing a nice work-life balance

    A social fund related to the important events in your life (marriage, birth, retirement, etc.)

    Our collective labor agreement that offers many benefits (seniority leave, social leave, medical check-up hours, individual performance bonuses, etc.)

    The prospect of a brand-new industrial site 4.0 in Bissen (in 2025)

    A location easy to access to 3 minutes' away from Lintgen's train station, as well as a free parking

    Attractive prices for health coverage (Foyer)

    Preferential rates for your telephone package (Tango Card)

    The Sympass card and its many good deals

    Benefits with a Luxembourgish bank (BGL)

    The sponsoring of some local sports events (football tournaments, football team, running or trail, individual or team events, etc.)

    Various company events (family day, Christmas party, team building, etc.)