Medical Device Expert
vor 2 Wochen
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, including Research & Development, Quality Management, Regulatory Affairs, Production, and Commercialization.
agap2 offers a permanent contract for highly qualified specialists with a background in engineering and life sciences for operative industry projects.
Tasks
- Oversight of ongoing MDR compliance work
- Support technical activities within the development of medical devices/combination products
- Support medical devices development, from early phase activities up to commercialization and production scale-up
- Compile technical documentation: Design History File, Design Control process, and other applicable regulatory, QA, and GMP aspects
- Understanding of medical devices regulations (FDA, 21CFR 820, MDR, MDD)
- Testing and verification (development of methods and equipment)
- Understanding of Human Factors Engineering and Risk Management
**Requirements**:
- Bachelor, Master's diploma, Ph.D. or equivalent in Engineering, Chemical or Biological Engineering, or related scientific field
- Working knowledge in GMP or MDD/MDR and ISO13485 is required
- Experience in a Medical Device regulated environment is mandatory (minimum 1year)
- Good knowledge of MDR, ISO 13485, and GMP in general
- General understanding of Risk Management
- English Fluent, German is a plus
You will have a technical manager at your side who will accompany, support, and prepare you for the next step of your career at agap2. Furthermore, you can expect a collegial team in a dynamic working atmosphere, extensive development opportunities, and the prospect of quickly taking on responsibility and actively shaping the future of the company.
-
Risk Manager Medical Device
Vor 3 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...
-
Risk Manager Medical Device
Vor 3 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 2 Wochen
Zurich, Schweiz agap2 - HIQ Consulting Vollzeitagap2 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,...
-
Zurich, Schweiz Lumendo AG VollzeitDo you look for an internship to get your first working experience? Would you like to work in a young, fast-moving startup in a highly-diverse, motivated team? Would you like to do engineering and prototyping, which will turn into a real product to improve people's life? Then contact us! Project description Root-canal treatments are among the most...
-
Clinical Evaluation Expert
Vor 7 Tagen
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...
-
Electric Safety Expert
vor 1 Woche
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...
-
Internship - Medical Communications
vor 23 Stunden
Zurich, Schweiz H+O communications Ltd. VollzeitWe are a full-service medical communications agency and publishing house in Zurich, London and Berlin, that specializes in the healthcare industry. Our customers include pharmaceutical, diagnostics and medical device companies. For this reason, our team comprises pharmaceutical and communications specialists. This combination enables us to develop tailored...
-
Internship - Medical Communications (a)
vor 2 Wochen
Zurich, Schweiz H+O communications Ltd. VollzeitWe are a full-service communications agency that specializes in the medical industry. Our customers include pharmaceutical, diagnostics and medical device companies. For this reason, our team comprises pharmaceutical and communications specialists. This combination enables us to develop tailored solutions for our customers. H+O communications offers you a...
-
Internship - Medical Communications (a)
vor 2 Wochen
Zurich, Schweiz H+O communications Ltd. VollzeitWe are a full-service communications agency that specializes in the medical industry. Our customers include pharmaceutical, diagnostics and medical device companies. For this reason, our team comprises pharmaceutical and communications specialists. This combination enables us to develop tailored solutions for our customers. H+O communications offers you a...
-
Clinical Regulatory Affairs Manager
vor 2 Wochen
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...