Regulatory Affairs Manager

Vor 4 Tagen


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



  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **SUMMARY** Responsible for - ** Regulatory Affairs** Obtain and maintain marketing authorizations for products and communication of general regulatory requirements in support of licensing of Takeda’s products **TASKS AND RESPONSIBILITES** - Manage **MA lifecycle maintenance** for a defined product portfolio, inclusive local impact assessments of global...


  • Zurich, Schweiz Advanced Bionics Vollzeit

    Who we are You enjoy creating and innovating. You never stop striving for better. You take responsibility and you get results. You love being part of a team. Above all, you want your work to matter: Welcome to our world! At Sonova we create sense by bringing sound to life. Our innovative hearing care solutions help millions of people enjoy life’s...


  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...


  • Zurich, Schweiz Pfizer Vollzeit

    Regulatory Affairs Manager (M/F/d) time type: 60%/80%/100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing...


  • Zurich, Schweiz CSL Behring Vollzeit

    CSL Vifor is currently undergoing unprecedented growth and portfolio expansion within rare diseases, Nephrology and Cardiorenal therapeutic areas. A permanent global position in the Global Regulatory Affairs Labelling team has arisen. Which can be based at any of our CSL R&D Hubs (Maidenhead UK, Amsterdam, NL, Bern, CH, Zurich, CH, KOP, PA or Waltham,...


  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda**. Are you a strategic and visionary leader with a strong background in regulatory affairs within the...


  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    **People First** - At Takeda we are dedicated to improving the health and well-being of all people and bringing them the hope of a brighter future. It is our passion that transforms every job into meaningful action. **Our people are the heart of Takeda.** Our team is growing and for this we need bright minds with creativity and flexibility - what talent do...


  • Zurich, Schweiz Novavax, Inc. Vollzeit

    If you find science, speed, and success exhilarating, you have come to the right place. Novavax, Inc (Nasdaq:NVAX) is a biotechnology company that creates transformational vaccines that address some of the world’s most pressing infectious diseases. We have more than a decade of experience contending with some of the world’s most devastating diseases,...

  • Regulatory Affairs

    Vor 5 Tagen


    Zurich, Schweiz Proclinical Vollzeit

    Our client a global pharmaceutical company specializing in rare diseases, Nephrology and Cardiorenal therapeutic areas is looking to appoint a Regulatory Affairs Labelling manager in their Zurich offices. This is an excellent opportunity to gain global experience within RA labelling in a high performing team at a time when multiple new drug development...


  • Zurich, Schweiz Bernwald Personalberatung Vollzeit

    Unsere Mandantin ist ein Schweizer KMU, das sich in einer Nische im Pharmabereich erfolgreich etabliert hat. - In ihrem Auftrag suchen wir eine Persönlichkeit mit ausgeprägtem Verantwortungsbewusstsein als Regulatory Affairs Manager Pharma EU/CH (m/w/d). **IHRE AUFGABEN**: - Selbständiges Erstellen von CMC-Zulassungsdokumentationen - Termingerechte...


  • Zurich, Schweiz Pfizer Vollzeit

    Regulatory Affairs Manager (M/F/d) 80-100% This is what you can look forward to: - Overseeing assigned product portfolio of innovative prescription drugs with complex regulatory background - Handling entire regulatory lifecycle from initial MAAs to line extensions, labeling and CMC variations, renewals, PSUR submissions, etc. - Developing of submission...


  • Zurich, Schweiz Corza Medical Vollzeit

    Location: role can be located anywhere in Europe At Corza Medical, our mission is to support surgical providers with remarkable service, trusted performance, and outstanding value by creating an unmatched experience that stems from listening to the surgical experts themselves. Our product family is the result of years of experience championing surgeons and...


  • Zurich, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...


  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an **Associate Director, Global Regulatory Affairs Development GI** to be based in Zurich, Switzerland. **Here, you will be a vital contributor to our inspiring, bold mission.** **OBJECTIVE**: - Defines, develops and leads global...


  • Zurich, Schweiz Takeda Pharmaceutical Vollzeit

    Our team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** **OBJECTIVE**: - Effectively communicates the regulatory strategies, submission plans and timelines; assessment of the likelihood of success of the regulatory strategies and impact assessments of trends, regulations and changes related to...


  • Zurich, Schweiz Marco Fuhrer Vollzeit

    Deine Aufgabe - Der Erfolg unserer Kunden bei der Markteinführung regulierter Produkte ist dein Antrieb. Als Senior Consultant bist Du ein Fachexperte, der interdisziplinäre Teams befähigt. Als inspirierende Führungspersönlichkeit schaffst Du Klarheit über regulatorische Anforderungen und hilfst deinen Kolleg:innen und Kund:innen, pragmatische...


  • Zurich, Schweiz Hays Vollzeit

    **My duties** - Directing and overseeing short-team and long-term planning of clinical data acquisition for regulatory submission initiatives - Leading pre-market clinical investigations and post-market clinical follow-up of the clients’ medical devices, with the goal to reach earliest possible approval of regulatory submissions - Designing clinical data...

  • Legal Counsel

    Vor 5 Tagen


    Zurich, Schweiz SIX Vollzeit

    We drive the transformation of the financial markets. That’s why we invest in bright minds, in their ideas, knowledge and development. We do that by combining our best sides. ***Legal Counsel - Regulatory Affairs (80-100%)****: Zurich | working from home up to 60% | Reference 5181 The Legal & Regulatory team is responsible for all legal and regulatory...


  • Zurich, Schweiz RAHN AG Vollzeit

    Founded in 1940, based in Switzerland and family-owned RAHN-Group is renowned for exceptional products and outstanding innovative solutions. We are internationally active on the market with specialty chemicals for EnergyCuring, with high-quality active ingredients and special products for the Cosmetic industry. Years of experience, know how and competent...


  • Zurich, Schweiz agap2 - HIQ Consulting Vollzeit

    agap2 is a dynamic and rapidly growing company and employs more than 6000 people in ten European countries. With more than 200 employees in Switzerland, we are specialized in Life Science, MedTech, Pharma, BioTech, etc. Our offices in Switzerland are located in Basel, Zürich, and Lausanne. agap2 works successfully in all areas of the product life cycle,...