Aktuelle Jobs im Zusammenhang mit Regulatory Strategy Lead - Burgdorf BE, Bern - Ypsomed
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Regulatory Affairs Specialist
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Human Factors Engineering Team Lead
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Strategic Innovation Manager
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Strategic Innovation Manager
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Strategic Innovation Manager
vor 3 Wochen
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Strategic Innovation Manager
vor 4 Wochen
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Innovation and Growth Strategist
vor 21 Stunden
Burgdorf BE, Bern, Schweiz Ypsomed VollzeitMain Responsibilities• Identify potential growth areas for Ypsomed Delivery Systems, contributing to the company's forward-thinking initiatives.• Lead evidence-based financial analyses of drug delivery devices under development to determine the financial impact of proposed initiatives through commercial viability assessments.• Gather inputs from...
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Strategic Innovation Manager
vor 1 Monat
Burgdorf BE, Bern, Schweiz Ypsomed VollzeitKey ResponsibilitiesContribute to the company's forward-thinking initiatives by identifying potential growth areas for Ypsomed Delivery Systems.Lead evidence-based financial analyses of drug delivery devices under development to determine the financial impact of proposed initiatives.Develop and recommend device portfolio strategy, ensuring our future...
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Human Factors Engineering Manager
vor 3 Wochen
Burgdorf BE, Bern, Schweiz Ypsomed VollzeitJoin Our Human Factors TeamWe are seeking a highly skilled Human Factors Engineer to lead our Human Factors Engineering team and contribute to the development of innovative medical devices.Main ResponsibilitiesDevelop and execute Human Factors Engineering programs in accordance with industry standards and guidelines.Lead and develop a team of Human Factors...
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Strategic Innovation Manager
vor 2 Monaten
Burgdorf BE, Bern, Schweiz Ypsomed VollzeitAbout YpsomedYpsomed is a leading company 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 Switzerland.Our MissionWe enable people to self-treat chronic diseases such as diabetes, obesity, and certain...
Regulatory Strategy Lead
vor 2 Monaten
About the Role
We are seeking a highly skilled Regulatory Affairs professional to join our team at Ypsomed. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our combination products and medical devices with regulatory requirements.
Key Responsibilities
- Develop and implement regulatory strategies to support the development, support, and deployment of combination products and medical devices.
- Manage regulatory responsibilities associated with product submissions, including preparation of worldwide product submission documents.
- Partner with business stakeholders to ensure regulatory compliance and support life-cycle management activities.
- Review quality agreements with customers on regulatory aspects and cooperate in QMS ISO and CFR audits.
- Lead or support continuous improvement initiatives to enhance regulatory processes and procedures.
Requirements
- University degree in Engineering or Natural/Medical Sciences or equivalent experience.
- At least 2 years of professional experience in Regulatory Affairs with focus on combination products and/or medical devices.
- Project Management competences preferred.
- Excellent organizational and people skills.
- Ability to work in an international cross-functional organization.
- Very good English knowledge (C2), German is a plus (B1).
About Ypsomed
Ypsomed is a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. We develop and produce injection and infusion systems for self-medication with the Ypsomed Group. Our market-leading products and solutions enable people all over the globe to self-treatment despite chronic diseases such as diabetes, obesity, or certain types of cancer.