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    Regulatory Affairs Specialist

    Sulzer AG

    Sulzer AG, Haag, Switzerland

    CH-9469 Haag (Rheintal)

    Grossunternehmen

    1001 - 1000000 Angestellte

    Temporär: Nein Pensum: 100%
    Haag, Switzerland Sprache: en

    Original Inserat / Bewerben

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    #LI-medmix

    Regulatory Affairs Specialist - Full Time - Haag, Switzerland

    At medmix, our team is focused on a single mission, to provide innovative solutions that help millions of people live
    healthier and more confident lives. Join us to expand your career opportunities in a high growth business, where your
    unique skills are valued.

    Join our team in Haag and help shape our future Regulatory Affairs agenda.

    In this role you will be accountable for:

    - Compliance with regulatory, legal and normative requirements for SMS
    - Review and cooperation in the preparation of the technical documentation
    - Support the UDI implementation
    - Ensuring product approval in accordance with country-specific regulations
    - Observation and management of standards and directives, information on changes
    - Participation in system maintenance of ISO 13485
    - Assisting in the implementation of the requirements of authorities, directives, customers and standards
    - Technical clarification and assessment of customer and authority requirements
    - Preparation and maintenance of system and technical documentation
    - Implementation of worldwide product approvals
    - Preparation and implementation of specialist employee training (GMP, hygiene, standards, etc.).
    - Duty to report to superiors in case of violation of legal compliance in medical devices issues
    - Support of requests from Industry segment- REACH/SVHC, RoHS and other directives and regulations

    To succeed in this role, you will need:

    - Technical or scientific degree (e.g. engineering, biology, chemistry) or equivalent profound work experience
    - 5 years of professional experience in research and development or quality management
    - 5 years of regulatory affairs experience for medical devices in the EU and / or international markets
    - Well-founded knowledge of MDR, GMP, ISO 13485, ISO 14971 and ISO 10993
    - Pronounced evaluation and decision-making skills
    - Analytical capability as required in reviewing, assessing and interpreting the relevant requirements
    - Proactive personality with hands-on-mentality, strong communication skills and decisiveness
    - German and English on a business fluent level

    Your benefits:

    - An innovative, vibrant and agile culture
    - A dynamic business on a growth trajectory
    - Excellent social benefits
    - Opportunity to work remotely

    Do you have a question about the role? Reach out to Mandy Della Volpe at mandy.dellavolpe@medmix.com . Please use our
    Online-Tool to apply for this position.

    We are looking forward to hearing from you!

    About us

    medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer
    and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that
    has resulted in over 900 active patents. Our 13 production sites worldwide together with our highly motivated and
    experienced team of over 1’900 employees provide our customers with uncompromising quality, proximity and agility.
    medmix is headquartered in Baar, Switzerland.

    Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).
    www.medmix.swiss

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