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Regulatory Affairs Manager

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Zurich, Schweiz Bruker Vollzeit

Überblick: Workload: 80 - 100% Place of work: Fällanden, Switzerland Department: Quality and Regulatory Affairs Start of contract: Immediately or by agreement Aufgaben/Verantwortlichkeiten: - Team member in a team of 5 Regulatory Affairs professionals, positioned in several countries, with Production Sites close to Zurich CH (manufacturer site), Karlsruhe GER and Strasbourg FR (some travel required; remote work option with 2 days out of 5 home office) - IVD (e.g., EU IVDR) compliance roll out in an international analytical instrumentation life sciences company - from approval process (e.g., TechDoc review) to day-to-day support of internal stakeholders (e.g., for performance studies) and execution of UDI implementation, multi-country registrations and post-market-surveillance activities. - Ensure international product compliance of medical devices (IVDs) in a pro-active and pragmatic, but always compliant way Qualifikationen: - Academic degree in a relevant field - Proven multi-year experience in the medical device (MD or IVD) or life sciences industry in the field of quality and/or regulatory affairs - Proven project management skills, international and cross-country exposure a plus - Fluent in English including presentation and trainer skills, German and/or French a plus - Ability to interact and align with various stakeholders - from Board level to peer groups - Strong track record in prioritizing and simultaneously managing and/or supporting multiple IVD-related projects in a fast-paced environment **What we offer** - Home office possibility with 41.5 hours per week - Future-oriented and diverse company with modern workplaces - At least five weeks of vacation and additional days off - Free parking garage on the company premises - Cost absorption of the SBB Half-Fare Card - Good social benefits and insurance - Diverse opportunities for further development in Switzerland and globally - Promotion of health and sports with various initiatives and an in-house fitness studio - Work location with local recreation area (Greifensee) - Our staff restaurant "Food Spin" with freshly prepared menus and buffet every day **Who we are