Device Regulatory Strategy Lead

Vor 4 Tagen


Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

Requirements:

  • University degree 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)


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    About the Role:This is an exciting opportunity for a seasoned Regulatory Affairs professional to join our team in Switzerland. As a Regulatory Affairs Manager, you will play a key role in ensuring compliance with medical device regulations, supporting product development, and collaborating with cross-functional teams.


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    About the TeamWe are a successful, rapidly growing company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world.Key ResponsibilitiesDevelop and implement strategies to engage with patient communities and advocacy groups.Establish and maintain relationships with key opinion leaders, healthcare professionals, and...


  • Solothurn, 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, Solothurn, Schweiz Oberberg Vollzeit

    Job SummaryWe are seeking an experienced IT Systems Manager to lead our Business Unit Digital & IT team in Fribourg. As "Business Unit Digital & IT Lead", you will be responsible for managing, developing, and implementing information systems and services for our Parker Meggitt Business Unit.The ideal candidate will have at least 8 years of experience in...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    This is a part-time job that offers the opportunity to work in a dynamic and growing organization. We are seeking a highly experienced Director, Corporate Affairs and Reputation Management to join our team in Switzerland.As a key member of our International Corporate Affairs team, you will play a critical role in supporting our Rare Disease Lead in...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    Overview of the PositionAs a Regulatory Affairs Expert at TN Switzerland, you will play a key role in supporting the development and implementation of global clinical research projects.Key ResponsibilitiesSupport the development and implementation of global clinical research projects.Collaborate with key opinion leaders, healthcare professionals, and...


  • Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit

    **Job Description:**We are seeking a talented Senior PV Scientist to fill the position of Pharmacovigilance Manager Leader at Experis Switzerland. As a key member of our Safety team, you will be responsible for managing pharmacovigilance activities, leading signal management processes, and collaborating with cross-functional teams.About Experis...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    We are looking for a highly skilled Senior PV Scientist to join our team at TN Switzerland.In this role, you will be responsible for leading the development of Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).A typical day might include:Working on post-marketing and/or investigational product to...

  • Senior PV Strategist

    Vor 4 Tagen


    Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    At TN Switzerland, we are seeking a Senior PV Scientist to serve as a global product lead for Pharmacovigilance activities within the Safety department.This role will involve managing PV Scientist(s) assigned to products within the designated portfolio.Key Responsibilities:Leads the signal management process for assigned product(s) and evaluates safety data...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    About the RoleWe are seeking a highly skilled Medical Innovations Specialist to join our team at TN Switzerland. As a key member of our scientific services department, you will be responsible for driving strategic decisions through medical assessments and insights.Key ResponsibilitiesPerform in-depth medical assessments of technologies and therapies for the...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    About the JobWe are looking for a highly motivated Scientific Solutions Developer to join our team at TN Switzerland. In this role, you will be responsible for developing and delivering medical and educational training programs to support the adoption of Ypsomed's solutions.Key ResponsibilitiesDevelop, maintain, and deliver medical and educational training...

  • PV Reporting Expert

    Vor 4 Tagen


    Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    As a PV Reporting Expert at TN Switzerland, you will be responsible for managing the processes for all aggregate reports (PSURs, DSURs, PADERs, and local reports) in compliance with global PV regulations. You will serve as a subject matter expert on aggregate reporting safety requirements worldwide.Key Responsibilities:Project management and authoring of...


  • Solothurn, Solothurn, Schweiz Michael Page Vollzeit

    Key ResponsibilitiesLead reviews and approvals of GMP Engineering and Manufacturing documents to ensure compliance with regulatory requirements.Partner with manufacturing, sciences, process engineering, and automation SMEs to drive quality improvements.Implement and maintain effective quality control measures to prevent nonconformities.Develop and deliver...


  • Solothurn, Solothurn, Schweiz Michael Page Vollzeit

    GMP Manufacturing ProfessionalWe are seeking an experienced GMP Manufacturing Professional to join our team. As a key member of the Integrated Downstream Quality Operations Team, you will be responsible for ensuring the quality and integrity of our products.You will lead reviews and approvals of GMP Engineering and Manufacturing documents to ensure...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    Job Description:About the RoleWe are seeking a highly experienced Senior Manager, Global Communications Strategy to join our team in Switzerland. As a key member of our International Corporate Affairs team, you will play a critical role in supporting our Rare Disease Lead in developing and implementing an integrated communications strategy that drives...


  • Solothurn, Solothurn, Schweiz Oberberg Vollzeit

    About the RoleThis exciting opportunity allows you to join Oberberg's dynamic team and contribute to the success of our Parker Meggitt Business Unit.As "Business Unit Digital & IT Lead", you will be responsible for driving digital transformation and improving business processes through effective IT management.You will work closely with our Site Management...


  • Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit

    **About the Role:**We are seeking an experienced Senior PV Scientist to join our team as a Global Safety Lead. This individual will be responsible for managing pharmacovigilance activities, leading signal management processes, and collaborating with cross-functional teams.About Experis Switzerland:Experis Switzerland is a trusted partner for businesses...


  • Solothurn, 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...


  • Solothurn, Solothurn, Schweiz TN Switzerland Vollzeit

    We are seeking a highly experienced Manager, International Communications to join our team in Switzerland. As a key member of our International Corporate Affairs team, you will play a critical role in supporting our Rare Disease Lead in developing and implementing an integrated communications strategy that drives business results.Your primary responsibility...

  • PV Team Director

    Vor 4 Tagen


    Solothurn, Solothurn, Schweiz Experis Switzerland Vollzeit

    **Our Ideal Candidate:**We are seeking a highly motivated and experienced Senior PV Scientist to join our team as a PV Team Director. As a leader in the field of pharmacovigilance, you will be responsible for managing pharmacovigilance activities, leading signal management processes, and collaborating with cross-functional teams.About Experis Switzerland:We...