Regulatory Affairs Manager.
vor 1 Tag
Focus of this position:
- Supporting our rapidly developing Diabetes Care (active and connected devices)
- Manage the development and implementation of regulatory strategies
- Support and prepare product submission documents with main focus on EU and US
- Partner with business stakeholders on different levels
- Communication and correspondence with authorities
- Cooperation in QMS ISO and CFR audits
- General QM tasks (Creation of Q-documents, trainings etc.)
Your profile:
- University degree preferably in Engineering or Natural/Medical Sciences or equivalent experience
- At least 4 years of professional experience in Regulatory Affairs with focus on medical devices
- Expertise in Active Medical Devices related regulations and guidance documents in EU and US
- Excellent organizational and people skills
- Very good English knowledge (Level C2 or MT)
Working hours:
Shiftwork, annual working hours, part-time
Your benefits:
- FlexWork: Work where and when you want (in Switzerland)
- Up-to-date work environment: Up-to-date production, offices, break areas
- Pension fund: Ypsomed covers % of the pension contributions
- Mobility support: Charging stations, Swiss Half Fare Card, parking, close to public transport
- Free sport facilities: Affordable or free gyms all over Switzerland
- Family friendly: Financial contributions to childcare
About Ypsomed:
More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treat chronic diseases such as diabetes, obesity, or certain types of cancer, providing them with the greatest possible quality of life.
#J-18808-Ljbffr-
Regulatory Affairs Manager
vor 1 Woche
Kanton Solothurn, Schweiz Ypsomed VollzeitIm Bereich QM & RA in der Abteilung Regulatory Affairs suchen wir am Standort Solothurn in der Schweiz eine technisch versierte Persönlichkeit als **Regulatory Affairs Manager**: **Ref-Nr. 3589**: **100%**: **Regulatory Affairs Manager**: **100%**: **Ihre Hauptaufgaben**: - Fokus von dieser Stelle ist die Unterstützung unserer single-use sterile medical...
-
Regulatory Affairs Manager
Vor 5 Tagen
Kanton Solothurn, Schweiz Ypsomed VollzeitAt our site in Burgdorf in the field of Regulatory Affairs, we are looking for a personality as a **Regulatory Affairs Manager**: **Ref. No. 4405**: **100%**: **Regulatory Affairs Manager**: **100%**: **Your main tasks**: - Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical...
-
Regulatory Affairs Manager
Vor 5 Tagen
Kanton Solothurn, Schweiz Ypsomed VollzeitAt our site in Burgdorf in the field of Regulatory Affairs, we are looking for a personality as a **Regulatory Affairs Manager**: **Ref. No. 4405**: **100%**: **Regulatory Affairs Manager**: **100%**: **Your main tasks**: - Accountable for the definition of regulatory strategies and the preparation of submission documents of reusable pen injector medical...
-
Regulatory Affairs Manager
Vor 2 Tagen
Solothurn, Schweiz Ypsomed VollzeitIn the Business Area Diabetes Care we are looking in Solothurn for an experienced skilled personality as a **Regulatory Affairs Manager **| 80 - 100%**: Ref. No. 6142 - Location: - SolothurnSupport us in the production and development of cutting-edge medical technology solutions that enable people around the world to self-manage diabetes and other chronic...
-
Regulatory Affairs Manager
vor 23 Stunden
Solothurn, Schweiz Ypsomed VollzeitIn the Business Area Diabetes Care in Solothurn we are looking for an experienced skilled personality as a **Regulatory Affairs Manager | **100%**: Ref. No. 6448 - Location: - Solothurn- | HybridHelp us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach. **Your main...
-
Regulatory Affairs Expert
Vor 4 Tagen
Solothurn, Schweiz Helvetica Partners VollzeitWe are currently looking on behalf of one of our important clients for a Regulatory Affairs Expert. The role is a permanent position based in Solothurn Canton. Your Role: - Carry out tasks to support a rapidly developing digital offering. - Support & prepare product submission documents, with main focus on USA, Canada, China, & the EU. - Prepare regulatory...
-
Regulatory Affairs Manager.
Vor 2 Tagen
Solothurn, Schweiz Ypsomed VollzeitYour main tasks Focus of this position is supporting our rapidly developing Diabetes Care (active and connected devices) Manage the development and implementation of regulatory strategies Support and prepare product submission documents with main focus on EU and US Partner with business stakeholders on different levels Communication and...
-
Quality Assurance Manager
Vor 2 Tagen
Solothurn, Schweiz Ypsomed VollzeitIn the Quality Management, Regulatory & Medical Affairs area in the Quality Assurance department, we are looking for a customer-oriented and quality-conscious personality in the Production Management Team at the Solothurn site as a **Quality Assurance Manager **| 80 - 100%**: Ref. No. 6219 - Location: - Solothurn- | HybridHelp us bring to market...
-
QMS Application Manager.
vor 12 Stunden
Solothurn, Schweiz TN Switzerland VollzeitKraftort.Ypsomade. Zur Verstärkung suchen wir im Bereich Quality Management, Regulatory & Medical Affairs am Standort Solothurn eine erfahrene und kompetente Persönlichkeit alsQMS Application Manager| - %Ref-Nr. 9 Arbeitsort: Solothurn |Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer strukturierten...
-
Quality Assurance Manager.
vor 1 Tag
Solothurn, Schweiz TN Switzerland VollzeitKraftort.Ypsomade. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit alsQuality Assurance Manager| - %Ref-Nr. 7 Arbeitsort: Solothurn , Burgdorf |Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu...
-
Quality Assurance Manager.
vor 1 Tag
Solothurn, Schweiz Ypsomed VollzeitKraftort. Ypsomade. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit als Quality Assurance Manager | - % Ref-Nr. 7 Arbeitsort: Solothurn , Burgdorf | Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf...
-
QMS Application Manager.
vor 1 Tag
Solothurn, Schweiz Ypsomed VollzeitKraftort. Ypsomade. Zur Verstärkung suchen wir im Bereich Quality Management, Regulatory & Medical Affairs am Standort Solothurn eine erfahrene und kompetente Persönlichkeit als QMS Application Manager | - % Ref-Nr. 9 Arbeitsort: Solothurn | Hybrid Helfen Sie uns, modernste Medizintechnik-Lösungen auf den Markt zu bringen, indem Sie dank Ihrer...
-
Marketing & Customer Manager
Vor 5 Tagen
Solothurn, Schweiz Ypsomed VollzeitGiven our dynamic business environment and continued success, we are looking for qualified talent to meet our growing demand and further strengthen our competitive position. **Marketing & Customer Manager | **100%**: Ref. No. 6524 - Location: - Solothurn- | HybridSupport us in the production and development of cutting-edge medical technology solutions that...
-
Quality Engineer
vor 1 Woche
Solothurn, Schweiz Ypsomed AG VollzeitAufgrund unseres anhaltenden Wachstums suchen wir engagierte und motivierte Mitarbeiterinnen und Mitarbeiter, um unsere Erfolgsgeschichte weiter voranzutreiben. Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Solothurn eine kundenorientierte und qualitätsbewusste Persönlichkeit...
-
Clinical Research
Vor 2 Tagen
Solothurn, Schweiz TN Switzerland VollzeitSocial network you want to login/join with:Clinical Research & Evaluation Manager, SolothurnClient: YpsomedLocation: SolothurnJob Category: OtherJob Reference: 90956b1906f3Job Views: 10Posted: 21.01.2025Expiry Date: 07.03.2025Job Description:Responsible for overseeing global clinical trials, ensuring compliance with ISO, the Declaration of Helsinki, and...
-
Manager HSE
vor 9 Stunden
Solothurn, Schweiz TN Switzerland VollzeitOur client is a leading company in the industrial machinery sector, known for delivering innovative and high-quality solutions to a diverse range of industries. Committed to excellence, they prioritize safety and quality in their products and services, ensuring a safe working environment for their employees and clients.Your responsibilities:Strategic...
-
Emea Velys Clinical Training Manager
Vor 2 Tagen
Solothurn, Schweiz Johnson & Johnson Vollzeit**Johnson & Johnson MedTech **is recruiting for 2 EMEA VELYS Clinical Training Managers (CTM) preferred location is Switzerland but other considered locations - UK, Germany, Italy or Austria. The roles will warrant a close and collaborative partnership with their global, North America & Asia-Pacific peers to evolve the VELYS education and support the...
-
Scientific Services Manager., Solothurn
Vor 2 Tagen
Solothurn, Schweiz TN Switzerland VollzeitYour main tasksPerform medical assessments of technologies and therapies for the treatment of diabetes and translate into comprehensible insights to drive strategic decisionsDevelop, maintain and deliver medical and educational training programs to support the adoption of Ypsomed's solutionsCreate scientific materials to support the dissemination of clinical...
-
Scientific Services Manager.
vor 1 Tag
Solothurn, Schweiz Ypsomed VollzeitYour main tasks Perform medical assessments of technologies and therapies for the treatment of diabetes and translate into comprehensible insights to drive strategic decisions Develop, maintain and deliver medical and educational training programs to support the adoption of Ypsomed's solutions Create scientific materials to support the...
-
Human Factors Manager.
Vor 2 Tagen
Solothurn, Schweiz TN Switzerland VollzeitSocial Network You Want to Login/Join With:Your Main Tasks:Responsibility for planning and execution of Human Factors Engineering programs according to current standards and guidelines (IEC, FDA HFE Guidance, etc.)Planning, coordination and monitoring of formative and summative HF studies (with internal and external researchers)Analysis, interpretation and...
