Clinical Affairs and Vigilance Manager

vor 1 Woche


Basel, Schweiz STORZ MEDICAL AG Vollzeit

Für den Ausbau unseres klinischen Teams suchen wir einen

Clinical Affairs and Vigilance Manager - 100% (m/w/d)

Ihre Hauptaufgaben
- Planung und Durchführung von Aktivitäten zur Marktüberwachung (Vigilanz):

- Erfassen und Analysieren von Vorkommnissen
- Meldungen von Vorkommnissen, FSCA, FSN an Nationale Behörden
- Durchführung von klinischen Bewertungen
- Planung und Durchführung von Aktivitäten zur klinischen Überwachung nach dem Inverkehrbringen (PMCF)
- Unterstützung bei der Planung und Durchführung klinischer Prüfungen von Medizinprodukten nach EN ISO 14155 und MDR 2017/745

Ihr Profil
- Hochschulabschluss im Bereich Gesundheitswissenschaften, Lebenswissenschaften, Medizintechnik oder vergleichbar
- Relevante Berufserfahrung
- Fortgeschrittene Kenntnisse im wissenschaftlichen Arbeiten, insbesondere im Bereich der evidenzbasierten Medizin
- Erfahrung in der systematischen Bewertung klinischer Daten und Erstellung wissenschaftlicher Berichte
- Erfahrungen in der klinischen Forschung sind wünschenswert
- Kenntnisse relevanter gesetzlicher, regulatorischer und normativer Vorgaben (MDR 2017/745, MEDDEV 2.7/1 Rev.4, MEDDEV 2.12-1 Rev.8, EN ISO 14155, MDCG)
- Präzise und selbstständige Arbeitsweise
- Kommunikationsstärke, Teamfähigkeit und Eigeninitiative
- Sehr gute Deutsch
- und Englischkenntnisse in Wort und Schrift

Wir bieten
- Einen interessanten und modernen Arbeitsplatz in einem innovativen und wachsenden Unternehmen
- Eine spannende Tätigkeit in einer zukunftsträchtigen Branche
- Eine umfassende und gezielte Einführung und eine kollegiale Arbeitsatmosphäre
- Ein hohes Mass an eigenverantwortlicher Arbeitsorganisation
- Flexible Arbeitszeiten und gute Sozialleistungen

Wir suchen eine selbstständige und verantwortungsbewusste Persönlichkeit. Sie zeichnen sich durch eine analytische Denkweise, Teamfähigkeit, Zielorientierung und exakte Arbeitsweise aus. Zudem arbeiten Sie zuverlässig mit sehr hohem Qualitätsbewusstsein.



  • Basel, Schweiz BeiGene Vollzeit

    General Description: - Accountable for regional study delivery with appropriate inspection readiness quality, within agreed timelines and budget - Leads the regional clinical operations team (including oversight of external partners working on the regional level) and acts as point of escalation for resolution of issues within the region for the assigned...

  • Safety Director

    Vor 2 Tagen


    Basel, Schweiz BioTalent Vollzeit

    **You will be Responsible For**: - Expertise in clinical interpretation of safety assessments and device safety reports. - High level response to regulatory authority requests - Develop safety materials and reports - Safety assessment for signals or issues - Risk management, Investigator brochures etc **You will bring the following**: - Health care...


  • Basel, Schweiz Evergreen Theragnostics Vollzeit

    Direct message the job poster from Evergreen TheragnosticsVice President Human Resources | Senior Human Resources ProfessionalClinical Quality Assurance (QA) Manager and AuditorEvergreen Theragnostics, Inc. is a radiopharmaceutical company headquartered in Springfield, NJ. We operate in a brand-new state-of-the-art facility, developing our own...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** **Contract Manager within Global Medical Affairs - 5854 LBD** We are looking for a highly motivated Contract Manager within Global Medical Affairs for our client, a major pharmaceutical company based in Basel City, Switzerland. GMA Contract Manager is responsible for having oversight of all GMA third-party contracts...


  • Basel, Schweiz NonStop Consulting Vollzeit

    We are looking for a Clinical Development Medical Director (CDMD) who is responsible for leading the strategic planning and management of the assigned clinical programs from an end-to-end clinical development perspective. As the CDMD, you will oversee the clinical development of the assigned programs and drive the implementation of the clinical development...


  • Basel, Schweiz Lonza Vollzeit

    Title: Manager, Regulatory Affairs (CMC)Hybrid working pattern: 2 WFHLocation: Basel or VispRelocation support is provided – subject to criteria.Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working...


  • Basel, Schweiz DSM Vollzeit

    **DSM - Bright Science. Brighter Living.** **What you’ll do**: - As a Regulatory Affairs Manager, you will manage the regulatory compliance, market clearance, advocacy and business support of DSM animal nutrition products and provide advice to Marketing and Sales, Product Management, Global Regulatory in all regulatory related topics/issues for Animal...


  • Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting a Regulatory Affairs Manager - CMC for a pharmaceutical organisation. This role is on a contract basis and is located in Basel. *** **Responsibilities**: - Offer regulatory assistance for projects and project teams. - Write, evaluate and offer contribution from a CMC perspective on pertinent documents necessary for clinical...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...


  • Basel, Schweiz BeiGene Vollzeit

    Summary As a Contract Manager, you will be working as part of contract professionals responsible for the planning, drafting, negotiating, tracking and execution of clinical site/investigator contracts which may be subcontracted to an external service provider or managed internally. The Contract Manager will manage site/investigator contract negotiations...


  • Basel, 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...


  • Basel, Schweiz LHH Vollzeit

    We have an exclusive mandate for one of our clients in Medical Devices based in Canton of Neuchatel. As a Regulatory Affairs Manager, you will be responsible for: - Support new product development by using in-depth knowledge and understanding of US domestic and international medical device, regulations (including 510k, and International dossiers) - Lead...


  • Basel, Schweiz Alira Health Vollzeit

    Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Job Description...

  • Manager PMS

    Vor 3 Tagen


    Basel, Schweiz CAMLOG Biotechnologies GmbH Vollzeit

    Manager PMS / Clinical Evaluations (m/w/d)To further strengthen our team in Basel, Switzerland, we have an immediate opening for aManager PMS / Clinical Evaluations (m/w/d)Your Prospects:International employer with team-oriented working atmosphereIntensive training in all relevant areas of the companyModern work equipment and various amenities such as free...


  • Basel, Schweiz Universität Basel Vollzeit

    The Swiss Tropical and Public Health Institute (Swiss TPH) is a world-leading institute in global health with a particular focus on low - and middle-income countries. Associated with the University of Basel, Swiss TPH combines research, services, and education and training at the local, national and international level. About 850 people from more than 80...


  • Basel, Schweiz NonStop Consulting Vollzeit

    **Some of the responsibilities**: Manage the operational trial related activities in close collaboration with other functions Manage the selection of ESPs in collaboration with other functions Supervise the deliverables towards the Contract Research Organization (CRO) and ESPs selected for the trial, to ensure compliance with study protocol and in accordance...


  • Basel, Schweiz Bayer Sverige 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...


  • Basel, Schweiz Warman O'Brien Vollzeit

    **Responsibilities will include**: - Manage the operational trial related activities in close collaboration with other functions, such as: site initiations, site closures, import/export licenses for materials and IMP, eTMF set-up and maintenance, contracts execution and invoices, submissions to Health Authorities, submissions to Ethics...

  • Clinical Data Manager

    Vor 7 Tagen


    Basel, Schweiz PMI Vollzeit

    Critères de l'offre **L'entreprise**: PMI PMI Description du poste Clinical Data Manager - Neuchatel, Switzerland Be a part of a revolutionary change. At PMI, we've chosen to do something incredible. We're totally transforming our business, and building our future on smoke-free products. With huge change, comes huge opportunity. So, wherever you join...

  • Grant Manager 80-100%

    vor 1 Woche


    Basel, Schweiz Institute of Molecular and Clinical Ophthalmology Basel Vollzeit

    The Institute of Molecular and Clinical Ophthalmology Basel (IOB) seeks a highly motivated person as **Grant Manager**. IOB is a research institute combining basic and clinical research. Its mission is to drive innovations in understanding vision and its diseases and develop new therapies for vision loss. It is a place where your expertise will be valued,...