Clinical Regulatory Affairs Manager
Vor 3 Tagen
**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 collection strategies with internal clinical experts and external clinical and research partners, analyze collected PMCF data and oversee the execution of clinical studies
- Planning and conduction clinical evaluations of medical devices in accordance with MDR and FDA
- Negotiating with outside agencies to resolve key regulatory issues pertaining to the clinical evidence and/or clinical claims of medical devices
- Preparing responses to inquiries from regulatory authorities on the clinical evidence and/or claims of
- Review, evaluate, and compile clinical files and reports for regulatory submissions of medical devices
- Provide guidance on communication of claims and indications of medical devices to the marketing teams
**My qualifications**
- Advanced Degree in physiotherapy, occupational therapy, medicine, rehabilitation or human movement sciences or any other discipline with relevance to neurorehabilitation
- Professional working experience in clinical practice, clinical affairs, medical affairs and/or rehabilitation research
- Experience in conducting clinical evaluations for medical devices and providing clinical regulatory guidance throughout the product development lifecycle, including clinical study development and implementation, preferably for medical devices utilized in neurorehabilitation
- Proven ability to negotiate with outside agencies to resolve key regulatory issues pertaining to the clinical evidence and/or clinical claims of medical devices
- Strong clinical knowledge in neurorehabilitation.
- Strong knowledge of MDR, FDA, and Good Clinical Practice
- Preferred: Certification in Regulatory Affairs or other certification relevant to medical product development and/or audit
- Experience in medical writing
- Excellent communication skills
- Capable of interpersonal contacts and foster effective dynamics in interdisciplinary teams
- Business-Fluent in English and German
**My benefits**
- Exciting taks in a dynamic environment
- Excellent development opportunities in a growing medical technology company
**About Hays**
- With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.**My contact at Hays**
**My contact person**
Laura Feig
**Reference number**
629164/1
**Contact**
Phone:
+41-61-2250 - 522
-
Clinical Affairs Manager
Vor 7 Tagen
Zurich, Schweiz Sonova VollzeitWho 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 Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Clinical Affairs Manager
Vor 7 Tagen
Zurich, Schweiz Sonova AG VollzeitWho we are In a life without sound, our work provides meaning. As a leading provider of innovative hearing care solutions, we are not just a company that makes products: we are a team on a mission to help people enjoy the delight of hearing. To enable a life without limitations, we - through our core business brands Phonak, Unitron, Sennheiser, Advanced...
-
Regulatory Affairs Manager
vor 1 Woche
Zurich, Schweiz Corza Medical VollzeitLocation: 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...
-
Global Regulatory Affairs Labelling Manager
Vor 7 Tagen
Zurich, Schweiz CSL Behring VollzeitCSL 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,...
-
Regulatory Affairs Manager
vor 1 Woche
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...
-
Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Advanced Bionics VollzeitWho 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...
-
Internship in Clinical Affairs
vor 1 Woche
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Regulatory Affairs Manager
Vor 3 Tagen
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...
-
Internship in Clinical Affairs
Vor 5 Tagen
Zurich, Schweiz Lumendo AG VollzeitLumendo is a Medtech startup and a spin-off from ETH Zürich and EPFL Lausanne. We develop technologies to improve the efficiency and success rate of dental root canal treatments. Our goal is to improve the treatment by a disruptive cleaning technology and a novel, light-activated root canal filling material, thus helping people to keep their natural teeth...
-
Manager, Clinical Trial Regulatory Lead
Vor 6 Tagen
Zurich, Schweiz Takeda Pharmaceutical VollzeitOur team is growing and for this we need bright minds with creativity and flexibility - **what talent do you have?** - Objective / Purpose_:_ _ - Executes or oversees all activities related to the creation, submission, and maintenance of CTAs Globally (GEM and EUCAN region), in Europe through the EU Clinical Trial Information System (CTIS) or legacy...
-
Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Pfizer VollzeitRegulatory 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...
-
Head Regulatory Affairs Emerging Markets
Vor 2 Tagen
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...
-
Regulatory Affairs Manager
vor 1 Woche
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...
-
Eucan Regulatory Affairs Director
Vor 4 Tagen
Zurich, Schweiz Takeda Pharmaceutical VollzeitLeads all regulatory activities related to the creation, submission and maintenance of CTAs in Europe, through the EU Clinical Trial Information System (CTIS) or legacy processes in conformity with legal requirements and with Takeda’s global and regional internal procedures. - Accountable for oversight and tracking of CTA activities. Works in collaboration...
-
Zurich, Schweiz Novavax, Inc. VollzeitIf 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 VollzeitOur 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...
-
Regulatory Affairs Manager Pharma Eu/ch
Vor 4 Tagen
Zurich, Schweiz Bernwald Personalberatung VollzeitUnsere 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...
-
Clinical Project Manager
Vor 6 Tagen
Zurich, Schweiz BIOTRONIK VollzeitClinical Project Manager BIOTRONIK is one of the leading manufacturers of cardio - and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology...
-
Regulatory Affairs Manager
Vor 5 Tagen
Zurich, Schweiz Pfizer VollzeitRegulatory 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...
