Regulatory Affairs Manager

Vor 2 Tagen


Luzern, Schweiz LHH Vollzeit

Unser Mandat ist ein innovatives und global vernetztes Medizintechnikunternehmen, welches für sein Entwicklungs-Know-How im Bereich der medizinischen Diagnostik bekannt ist. Mit mehr als 15 Jahren Erfahrung und 100 Mitarbeitern in 4 Niederlassungen verzeichnet unser Mandant in den letzten Jahren ein starkes Wachstum und sucht zum nächstmöglichen Zeitpunkt Unterstützung durch einen **Regulatory Affairs Manager (m/w/d)** für die Niederlassung im Grossraum Luzern.

**Aufgabengebiet**
- Zuständig für die Vorbereitung und Unterstützung von internen Audits und Audits zur CE Zertifizierung des Medizinproduktes und des QM Systems nach ISO 13485
- Sie wirken bei der Koordination von Tätigkeiten im Bereich der Regulatory Affairs mit (insb. bei der Zulassung und Aufrechterhaltung)
- Mitarbeit in Projektteams und Schnittstelle zu anderen Fachabteilungen hinsichtlich der regulatorischen Anforderungen bei der Entwicklung und Erstellung sowie Aktualisierung von Dokumentationen
- Sie verantworten die Korrespondenz, Kommunikation und Kontaktpflege mit internationalen Partnern sowie Distributoren

**Anforderungsprofil**
- Vorzugsweise Studium der Naturwissenschaften, Medizintechnik oder abgeschlossene berufliche Ausbildung in vergleichbarer Fachrichtung
- Sie verfügen über Kenntnisse nationaler und internationaler Zulassungsverfahren
- Sie bringen Berufserfahrung im Bereich Regulatory Affairs oder Qualitätsmanagement mit
- Sie sind mit den Normen ISO 13485 und ISO 9001 vertraut
- Teamfähigkeit sowie sehr gute Deutsch
- und Englischkenntnisse in Wort und Schrift runden Ihr Profil ab

**Vergütungspaket**
- Attraktives Vergütungsmodell
- Betriebliche Altersvorsorge und vermögenswirksamen Leistungen
- Angenehme und persönliche Arbeitsatmosphäre in einem hochmotivierten Team
- Modern ausgestattete Arbeitsplätze



  • Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Project Manager, CMC Regulatory Affairs, LuzernClient:1925 GlaxoSmithKline LLCLocation:Job Category:OtherJob Reference:34e4ca8b5d9aJob Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of...


  • Luzern, Schweiz 1925 GlaxoSmithKline LLC Vollzeit

    At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong...


  • Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Clinical Affairs Coordinator (m/f/d), LucerneClient:HaysLocation:LucerneJob Category:OtherJob Reference:0a7b9b57121fJob Views:12Posted:21.01.2025Expiry Date:07.03.2025Job Description:Clinical Affairs Coordinator (m/f/d)Freelance/temporary employment for a project in Lucerne. Start date: asap. Reference number:...

  • Cra Manager

    Vor 7 Tagen


    Luzern, Schweiz MSD Vollzeit

    We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for...


  • Luzern, Schweiz MSD Vollzeit

    **Duration**: 6 months up to 2 years **Location**: Lucerne, Werftestrasse - Are you looking for an _**_internship _**_to learn and develop, take a peek into the professional world while bringing in your individual contribution? Would you like to experience working in one of the biggest multinationals in the pharmaceutical industry? We are looking for a...


  • Luzern, Schweiz MSD Vollzeit

    Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is comprehended. We unite, communicate and train internal employees to ensure a thorough comprehension of the science behind the medicine and review further unmet medical needs to...


  • Luzern, Schweiz Merck Gruppe - MSD Sharp & Dohme Vollzeit

    Job DescriptionOur Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is comprehended. We unite, communicate and train internal employees to ensure a thorough comprehension of the science behind the medicine and review further unmet...


  • Luzern, Schweiz MSD Vollzeit

    We are currently looking for a field based **Commercial Business Development Manager Vaccines (M/F/d)** with national responsibility who will maximize the growth of our private market vaccines sales across Switzerland. They will report to the Business Unit Director, Vaccines, and work closely with colleagues from a range of functions including Marketing,...


  • Luzern, Schweiz TN Switzerland Vollzeit

    Supply Chain Specialist - II - P2Client:CK GroupLocation:LucerneJob Category:OtherJob Reference:4e5629e02fa9Job Views:9Posted:21.01.2025Expiry Date:07.03.2025Job Description:Job Title: New Product Introduction Specialist (Supply Chain Specialist II)Work Location: LucerneDuration: 12 monthsYour main duties as a New Product Introduction Specialist will...


  • Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Job Title: Clinical Project Manager – VaccinesCompany Overview: Join a leading biotechnology company at the forefront of vaccine development, dedicated to improving global health through innovative solutions.Position Overview: The Clinical Project Manager (CPM) will oversee the planning, execution, and completion...


  • Luzern, Schweiz MSD Vollzeit

    Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is comprehended. We unite, communicate and train internal employees to ensure a thorough comprehension of the science behind the medicine and review further unmet medical needs to...


  • Luzern, Schweiz MSD Vollzeit

    **Our Animal Health Marketing team takes a customer centric perspective using customer feedback and market intelligence data. Using this data, we design, develop and deploy products, platforms, brands and marketing initiatives that ensure we can improve the health and well-being of animals everywhere.** The Key Account Manager (KAM) Poultry Switzerland...


  • Luzern, Schweiz TN Switzerland Vollzeit

    Facility Quality Compliance Manager, LucerneClient:CK GroupLocation:LucerneJob Category:OtherJob Reference:1f65679b93b3Job Views:10Posted:21.01.2025Expiry Date:07.03.2025Job Description:Facility Quality Compliance ManagerCK QLS are looking for a Facility Quality Compliance Manager to join a Global Biopharmaceutical company, based in Lucerne, for 12 months....


  • Luzern, Schweiz MSD Vollzeit

    Our Medical Affairs team advances patient care by engaging in scientific exchange with external medical experts and industry leaders ensuring the scientific value of our products is comprehended. We unite, communicate and train internal employees to ensure a thorough comprehension of the science behind the medicine and review further unmet medical needs to...


  • Luzern, Schweiz Alpinum Solutions AG Vollzeit

    Alpinum Solutions is a leading provider of managed legal services in Switzerland, Germany and Liechtenstein. For our latest mandate, we are seeking an exceptional talent in the following field:Position: Trade Compliance ManagerSector: IndustryStart Date: February 2025Duration: 12 monthsUtilization: 100%Location: Lucerne (hybrid)Salary: CHF...


  • Kanton Luzern, Schweiz Organon Vollzeit

    **The Position** - Effective leadership of the Safety Science (SS) team and effective cross - functional collaboration and engagement with Organon's business strategy and goals. - Controlled fulfillment of all legal obligations and company duty-of-care requirements relative to drug and device safety relating to SS activities. - Ensure that SS delivers...


  • Luzern, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:Client:Alpinum Solutions AGLocation:Lucerne (hybrid)Job Category:OtherJob Reference:d0e3c2dd9827Job Views:7Posted:21.01.2025Expiry Date:07.03.2025Job Description:Alpinum Solutions is a leading provider of managed legal services in Switzerland, Germany and Liechtenstein. For our latest mandate, we are seeking an...


  • Luzern, Schweiz MSD Vollzeit

    Our Marketing team are passionate about bringing our medicines and vaccines to our customers around the world. Through digital listening and patient analytics, we are able to understand our customers’ needs and strive to provide solutions to meet them. We are currently seeking a Brand & Customer Manager (BCM) who will be dedicated resource in the Oncology...


  • Luzern, Schweiz MSD Vollzeit

    Our Human Health Division maintains a “patient first, profits later” ideology. The organization is comprised of sales, marketing, market access, digital analytics and commercial professionals who are passionate about their role in bringing our medicines to our customers worldwide. The Sales Force Effectiveness Manager is responsible for sales force...


  • Luzern, Schweiz Veolia Vollzeit

    **Company Description**: **The Sonderabfallverwertungs-AG SOVAG,** a subsidiary of SARP Industries (a company of the VEOLIA Group) the leading player in Europe for the treatment and recovery of hazardous waste, is looking **for our Project in Emmenbrücke a motivated** **Junior Project Manager 100%** **What is our project about?**- Obtaining a permit for a...