Regulatory Affairs Manager

vor 7 Monaten


Solothurn, Schweiz Ypsomed Vollzeit

In 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 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 correspondence with authorities
- Cooperation in QMS ISO 13485 and 21 CFR 820 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 medical device
- 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)



  • Solothurn, Schweiz Ypsomed Vollzeit

    Angesichts unseres dynamischen Geschäftsumfelds und des anhaltenden Erfolgs suchen wir qualifizierte Talente, um unsere wachsende Nachfrage zu decken und unsere Wettbewerbsposition weiter zu stärken. **Regulatory Affairs Manager | **100%**: Ref-Nr. 6448 - Arbeitsort: - Solothurn- , Burgdorf- | HybridHelfen Sie uns, modernste Medizintechnik-Lösungen auf...


  • Solothurn, Solothurn, Schweiz Ypsomed Vollzeit

    Ypsomed is a rapidly growing family-owned company that develops and produces injection and infusion systems for self-medication worldwide.We are seeking an experienced Regulatory Affairs Manager to support our Diabetes Care team in developing and implementing regulatory strategies.The ideal candidate will have a university degree in Engineering or...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Your 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...


  • Solothurn, Schweiz Ypsomed Vollzeit

    In the area of Quality Management, Regulatory and Medical Affairs in Solothurn, we are looking for an experienced and passionate person to join the Medical Affairs team as a **Scientific Services Manager | **80 - 100%**: Ref. No. 6754 - Location: - Solothurn- | HybridSupport us in the production and development of cutting-edge medical technology solutions...

  • Risk Manager

    vor 6 Monaten


    Solothurn, Schweiz Ypsomed Vollzeit

    Wir sind ein aufstrebendes Unternehmen, das sich durch kontinuierliches Wachstum auszeichnet. Werden Sie Teil unserer Erfolgsgeschichte des Risk Management Teams in Solothurn und bringen Sie Ihre Fähigkeiten und Ideen in eine spannende Position ein. **Risk Manager | **80 - 100%**: Ref-Nr. 6890 - Arbeitsort: - Solothurn- | HybridHelfen Sie uns, modernste...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Im Bereich Quality Management, Regulatory & Medical Affairs in der Abteilung Quality Assurance suchen wir am Standort Burgdorf eine kundenorientierte und qualitätsbewusste Persönlichkeit als **Quality Assurance Manager | **80 - 100%**: Ref-Nr. 6367 - Arbeitsort: - Solothurn- , Burgdorf- | HybridHelfen Sie uns, modernste Medizintechnik-Lösungen auf den...


  • Solothurn, Schweiz Ypsomed Vollzeit

    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 | **80 - 100%**: Ref-Nr. 6367 - Arbeitsort: - Solothurn- , Burgdorf- | HybridHelfen Sie uns, modernste Medizintechnik-Lösungen auf den...

  • Marketing Manager

    vor 6 Monaten


    Solothurn, Schweiz Ypsomed Vollzeit

    Given 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 Manager | **100%**: Ref. No. 6524 - Location: - Solothurn- | HybridSupport us in the production and development of cutting-edge medical technology solutions that enable...

  • QMS Application Manager.

    vor 7 Monaten


    Solothurn, Schweiz Ypsomed Vollzeit

    Kraftort. 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...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Kraftort. 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...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Given 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...

  • Digital Project Manager

    vor 6 Monaten


    Solothurn, Schweiz WiiGroup Vollzeit

    Our Mission At WiiGroup, our mission is to revolutionise the AEC industry through innovative solutions, cutting-edge technology, and a relentless focus on client satisfaction. We strive to exceed expectations, leverage digitalisation, and shape the future of construction globally. Through innovative solutions and cutting-edge technologies. With a passionate...


  • 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...


  • Solothurn, Schweiz Ypsomed Vollzeit

    Your 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 7 Monaten


    Solothurn, Schweiz Ypsomed Vollzeit

    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 documentation of findings from...

  • Clinical Research

    vor 7 Monaten


    Solothurn, Schweiz Ypsomed Vollzeit

    Your main tasks Responsible for overseeing global clinical trials, ensuring compliance with ISO :0, the Declaration of Helsinki, and relevant national laws and regulations. This includes adherence to Articles through and Annex XV of EU Regulation 7/ (MDR), as well as adhering to clinical trial standards as governed by the Food and Drug Administration...


  • Solothurn, Schweiz Johnson & Johnson Vollzeit

    One of the key strategies in the digital transformation for Medical Devices EMEA is to ensure that we can target the right customers at the right time in their channel of preference. The future of customer interactions is about making every engagement count! It is about knowing our customers so well that we can build upon their preferences to create...


  • Solothurn, Schweiz Johnson & Johnson Vollzeit

    **_Caring for the worldone person at a time” _**inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo. **DePuy Synthes **Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the...

  • Training Coordinator

    vor 1 Monat


    Solothurn, Schweiz Johnson & Johnson Vollzeit

    Are you great at organizing knowledge and connecting dots? Do you enjoy having things in order and assuring that everything makes perfect logical sense? Are you the kind of person who is ready to find solutions to complex problems and stays level-headed when request pile up? Would you like to use these skills to improve lives of cancer patients at the...


  • Solothurn, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson is currently seeking a Digital Lead VELYS EMEA. DE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our...