Clinical Affairs Manager
vor 7 Monaten
Who 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 Bionics and AudioNova - develop, manufacture and distribute solutions that push the limits of technology and redefine the future of our industry.
As Clinical Affairs Manager, you will play a pivotal role in supporting the development and maintenance of clinical evaluation plans and reports. You will be responsible for ensuring all necessary evidence, including literature research and published papers, is obtained to substantiate claims and comply with medical devices regulations. Furthermore, you will collaborate closely with the Sonova Clinical Affairs team, ensuring that clinical evidence remains in alignment with regulatory requirements.
Your tasks
- Define and create comprehensive clinical development plans in collaboration with project and study teams
- Create and maintain clinical evaluation documentation for assigned projects or specific areas within the defined procedure
- Conduct systematic literature research to enhance clinical evidence
- Support the Clinical SOP Owner in keeping procedures and templates up-to-date
- Act as the first-level contact for guiding all departments involved in clinical studies through the process
- Review study request forms and provide support for ethic requests
- Assist with requests to competent authorities
- Ensure quality assurance for all documents related to studies, requests, plans, and reports
- Request, manage, and monitor studies as needed, ensuring adherence to established procedures
**Profile**:
- University degree in Science, Engineering or any related field of study
- Experience in the area of regulatory or clinical trials, preferably in the MedTech industry
- Ability to understand, interpret and explain complex device technical documentation
- Strong communication skills, with the ability to give presentations to a wide spectrum of audiences
- Ability to adapt swiftly in a dynamic, fast-paced environment
- Fluency in English, both written and spoken
- Good MS Office skills
**Offer**:
We can offer you a new challenge, with interesting tasks and much more - including an open corporate culture, flat hierarchies, support for further training and development, opportunities to take on responsibility, an excellent range of foods, sports and cultural facilities, attractive employment conditions, and flexible working time models in various roles. Employment level: 80 - 100%.
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
+41 58 928 01 01
-
Clinical Affairs Manager
vor 7 Monaten
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...
-
Project Manager Global Affairs
vor 7 Monaten
Zurich, Schweiz Global Affairs VollzeitGlobal Affairs_ **Project Manager Global Affairs (m/w/d)** **80 % **:Die Abteilung Global Affairs der Universität Zürich (UZH) fördert und pflegt die weltweite Zusammenarbeit der Universität mit Partnerhochschulen und Institutionen in der internationalen (bildungs-)politischen Landschaft und im akademischen Umfeld mit dem Ziel, die internationale...
-
Clinical Evaluation Manager
Vor 4 Tagen
Zurich, Schweiz Frank Recruitment Group VollzeitFor international company operating in medtech industry in Zürich we are currently looking for a Clinical Evaluation Manager. **Responsibilities**: - Manage the performance evaluation and review plans according to European Regulations - Create and maintain Performance Evaluation Plans (PEP) - Define relevant evaluation measures and design study...
-
Clinical & Regulatory Affairs Associate in Medtech
vor 2 Stunden
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 6 Tagen
Zurich, Schweiz NonStop Consulting VollzeitRegulatory Affairs Manager role - Switzerland (German) - CMC I am currently looking for an experienced Regulatory affairs manager, CMC to join a good reputation employer in a German canton of Switzerland. In your role you will be responsible for all CMC aspects, providing strategic and operational guidance to different teams in order to ensure achieving the...
-
Clinical Evaluation Manager
vor 2 Wochen
Zurich, Schweiz Proclinical VollzeitProclinical are recruiting a Clinical Evaluation Manager for a medical technology devices organisation on a permanent basis. As a Clinical Evaluation Manager, you will be handling the development of clinical strategies and submission documentation for first in ma, regulatory submission and post market trials for their class III...
-
Clinical Evaluation Manager
Vor 7 Tagen
Zurich, Schweiz BIOTRONIK VollzeitClinical Evaluation Manager (60-80%) As one of the world´s leading manufacturers of cardio - and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the...
-
Clinical Project Manager
vor 7 Monaten
Zurich, Schweiz SIVA Health AG VollzeitSIVA Health AG is a digital health startup company in the field of sound-based respiratory diagnostics, located in Zurich, Switzerland. Through collaboration with global corporate partners, clinics, and researchers, we at SIVA Health have developed a novel device to continuously measure cough (24/7). This innovation is currently being used in global clinical...
-
Global Regulatory Affairs Labelling Manager
vor 7 Monaten
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,...
-
Clinical Director, Clinical Research
vor 8 Monaten
Zurich, Schweiz MSD VollzeitWe are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and 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...
-
Clinical Evaluation Expert
vor 7 Monaten
Zurich, Schweiz Klenico Health VollzeitKlenico Health AG is a HealthTech company in Zurich and Berlin, which has set itself the goal of helping people with mental stress or illness. In cooperation with leading clinics in Europe, we have developed a web-based, CE-marked medical device software that guides healthcare professionals through the diagnostic process for mental disorders. We are...
-
Regulatory Affairs Manager
vor 2 Stunden
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...
-
Oncology, Global Director Medical Affairs Melanoma
vor 2 Stunden
Zurich, Schweiz MSD VollzeitThe Global Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs Plans for their assigned asset(s). The GDMA contributes substantially to and is a valued co-strategist on the Global Franchise Team and assigned Product Development (Sub-) Teams. The GDMA contributes to Life Cycle Management...
-
Clinical Trial Manager
vor 2 Wochen
Zurich, Schweiz Denali Therapeutics Vollzeit**Clinical Trial Manager** ***Denali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine. **The Opportunity** The Clinical Trial Manager (CTM) is responsible managing the day-to-day operations of assigned clinical studies...
-
Quality and Regulatory Affairs Manager
vor 3 Wochen
Zurich, Schweiz Wyss Zurich Vollzeit_Wyss Zurich_ **Quality and Regulatory Affairs Manager** **100 %**:The Wyss Zurich Translational Center is a joint accelerator of the University of Zurich and ETH Zurich (Swiss Federal Institute of Technology Zurich), which was made possible by a generous donation from the Swiss entrepreneur and philanthropist Dr. h.c. mult. Hansjörg Wyss. It was...
-
Clinical Studies Manager
vor 7 Monaten
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...
-
Regulatory Affairs Manager
vor 2 Wochen
Zurich, Schweiz Akina VollzeitAkina is a leading developer of medical software to empower patients during independent physiotherapy at home. With an AI-driven motion coach and unique entertainment integration, Akina addresses the lack of clinical feedback and motivation that causes 4 out of 5 patients to fail during self-care at home today. As a regulatory affairs manager at Akina, you...
-
Clinical Trial Manager
vor 2 Wochen
Zurich, Schweiz Numab Therapeutics AG VollzeitNumab Therapeutics AG, with its US subsidiary Numab US LLC, is an expanding, clinical stage Swiss biotech company based in Horgen, canton of Zürich. The company is focused on the discovery and development of novel, antibody fragment-based therapeutics. With our breakthrough antibody-discovery and multi-specifics engineering platform, we engage in...
-
Regional Director Medical Affairs- Mer Region
vor 2 Wochen
Zurich, Schweiz MSD VollzeitJoin a multi-award-winning leading biopharmaceutical company Be part of best-in-class Medical Affairs Team Your chance to be at the center of innovation and excellence in execution. The Regional Director of Medical Affairs (RDMA) for Women’s Cancer holds primary responsibility for developing and executing Oncology Global Medical Affairs strategies in...
-
Regional Director Medical Affairs- Mer Region
Vor 4 Tagen
Zurich, Schweiz MSD VollzeitJoin a multi-award-winning leading biopharmaceutical company - Be part of best-in-class Medical Affairs Team - Your chance to be at the center of innovation and excellence in execution. The Regional Director of Medical Affairs (RDMA) for Women’s Cancer holds primary responsibility for developing and executing Oncology Global Medical Affairs strategies in...