Risk Management Expert for Medical Devices

Main ResponsibilitiesEnsure the company's products meet the latest risk management standards, adhering to ISO 14971, ISO 13485, and ISO 62304 during development and lifecycle.Represent risk management in audits conducted by regulatory bodies, customers, and internal teams.Collaborate with cross-functional teams to ensure effective communication and...

Main ResponsibilitiesAs a Risk Management Specialist at Ypsomed, you will be responsible for ensuring that our products comply with the latest standards in risk management, specifically observing ISO 14971, ISO 13485, and Part 11 during product development and lifecycle.Key TasksRepresent risk management in audits conducted by Notified Bodies, Competent...

Main ResponsibilitiesDevelop and implement risk management strategies to ensure compliance with ISO standards and regulations.Represent risk management in audits and communicate effectively with stakeholders.Collaborate with cross-functional teams to ensure effective risk control measures.Contribute to the continuous improvement of risk management...

About the RoleAt Ypsomed, we're driving innovation in medical technology. We're looking for an experienced Human Factors expert to lead our Human Factors Engineering team and contribute to the development of user-centered medical devices.

Job DescriptionRisk Manager Role OverviewWe are seeking a highly skilled Risk Manager to join our team at Ypsomed, a leading manufacturer of injection and infusion systems for self-medication. The ideal candidate will possess excellent risk management expertise, strong communication skills, and the ability to work collaboratively with various teams.Key...

About the RoleWe are seeking a skilled Compliance Risk Specialist to join our team at Ypsomed. The ideal candidate will have a strong background in risk management, specifically in the areas of ISO and Part compliance.Key ResponsibilitiesEnsure compliance with the latest standards in risk management during product development and lifecycleRepresent risk...

Job DescriptionIn this critical role as Regulatory Affairs Manager, you will be responsible for ensuring the compliance of our combination products and medical devices within our delivery systems. Your expertise will drive regulatory strategies that support our business objectives.Main Responsibilities:Regulatory ComplianceManage regulatory responsibilities...

About the RoleSustainability innovation is at the forefront of our vision at Ypsomed. We are seeking a dedicated Sustainability Innovation Lead to drive our circular device initiatives and collaborate with stakeholders to translate our commitment to the Science Based Targets initiative (SBTi) into practical breakthrough projects.Main ResponsibilitiesManage...

Are you a motivated and innovative professional looking to bring state-of-the-art medical technology solutions to market? We have an exciting opportunity for a Regulatory Affairs Manager at our Burgdorf site.Job DescriptionAs a Regulatory Affairs Manager, you will play a key role in optimizing processes and ensuring quality through your structured approach....

Main ResponsibilitiesAs a Strategy and Innovation Manager, you will identify and explore potential growth areas for Ypsomed Delivery Systems, contributing to the company's forward-thinking initiatives. This involves leading evidence-based financial analyses of drug delivery devices under development to determine the financial impact of proposed initiatives...

Regulatory Affairs Manager Job DescriptionMain Responsibilities:Manage regulatory responsibilities for combination products and medical devices.Develop and implement regulatory strategies.Prepare worldwide product submission documents.Partner with business stakeholders.Support life-cycle management activities.Review quality agreements with...

As a leading company in our industry, Ypsomed has established a strong reputation through continuous growth. We are seeking an expert to join our Human Factors team in Burgdorf and contribute their expertise.Key Responsibilities:Develop and execute Human Factors Engineering programs according to current standards and guidelines.Lead and develop the Human...

Main ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance with relevant laws and regulations.Manage regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices.Partner with business stakeholders to ensure regulatory requirements are met.Support life-cycle...

Be Part of Our Innovation-Driven TeamAt Ypsomed, we are committed to shaping the future of medical technology. As a leading company in the industry, we have made a name for ourselves through continuous growth and innovation. We are now looking for a talented Human Factors Engineer to join our team in Burgdorf.Main Responsibilities:Lead and develop the Human...

Main ResponsibilitiesAs a key member of our Regulatory Affairs team, you will be responsible for managing regulatory responsibilities associated with the development, support, and deployment of combination products and medical devices within our business area delivery systems.Key TasksDevelop and implement regulatory strategies to ensure compliance with...

**Innovative Electronics for Medical Devices**As a leading company in our industry, we are committed to continuous growth and innovation. We are seeking an experienced Electronics Development Specialist to join our Research & Development department at our headquarters in Burgdorf.**Key Responsibilities:**• Drive and lead the analysis, concept generation,...

About the RoleWe are seeking a highly skilled Strategic Innovation Leader to join our team at Ypsomed. As a key member of our organization, you will play a crucial role in driving our company's forward-thinking initiatives and contributing to our growth and success.Key ResponsibilitiesLead evidence-based financial analyses of drug delivery devices under...

About Ypsomed AGYpsomed AG is a leading global company specialising in the development and production of injection and infusion systems for self-medication. With over 2,000 employees worldwide, we are a successful and rapidly growing family-owned business headquartered in Burgdorf, Switzerland.Overview of the RoleWe are seeking an experienced...

Beschreibung:Wir suchen eine motivierte und fähige Person als Test Planning Manager |, um Prozesse zu optimieren und die Qualität in unserem Unternehmen sicherzustellen.Hauptaufgaben:Festlegung der Wareneingangsprüfungen, IPC- Prüfungen und Endprüfungen in Zusammenarbeit mit dem Einkauf, Technology und Produktion.Entscheidungsbefugnis für die...

Bei der Simon Keller AG erwartet Dich eine Herausforderung in einem dynamischen und innovativen Umfeld. Als Kategorieverantwortlicher übernimmst Du die Führung für unsere Physio-, Wellness- und Medical-Kategorien.Deine AufgabenEigenständige Steuerung und Entwicklung deiner Produktkategorien über den gesamten Produktlebenszyklus, um einen Wachstumsmarkt...