Aktuelle Jobs im Zusammenhang mit Clinical Affairs Manager - Bern - machineMD
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Clinical Trial Manager
vor 2 Wochen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...
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Bern, Bern, Schweiz Multi Personnel Vollzeit CHF 60'000 - CHF 120'000 pro JahrReconnue et incontournable depuis 1976, Multi Personnel est une agence spécialisée dans la mise à disposition de personnel administratif et de cadres, temporaire et fixe, dans de nombreux secteurs économiques, tels que la banque, sociétés financières, multinationales, ONG, PME et institutions locales. Nous souhaitons recruter un/e Clinical &...
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Clinical Trial Manager
Vor 7 Tagen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IS A YOUNG NANOTECH COMPANY **with 50 employees, a number of promising drugs in preclinical and clinical development and its own clean room production. in the fields of oncology (gentle chemotherapy) and neurology (new approach to treat Parkinson's disease). In order to conduct further clinical trials with our Clinical Research Team based in...
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Bern, Schweiz We make it VollzeitBeschreibung: We make it GmbH is a company operating nationally in Switzerland, which has a high level of competence in the personnel services sector thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH...
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Regulatory and Clinical Affairs Associate
Vor 5 Tagen
Bern, Schweiz CASCINATION AG Vollzeit**Your mission**: Your Mission: You will play a key supporting role in the development and upkeep of regulatory documentation to ensure compliance with global standards. Key tasks include: - Support the creation, submission, and maintenance of regulatory documentation - Liaise with Research & Development to create and maintain technical files - Monitor...
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Regulatory Affairs Associate
vor 2 Wochen
Bern, Schweiz InnoMedica Holding AG Vollzeit**INNOMEDICA IST EIN JUNGES NANOTECH-UNTERNEHMEN** mit ca. 50 Mitarbeitenden, einer Reihe erfolgversprechender Medikamente in präklinischer und klinischer Entwicklung sowie eigener Reinraum-Produktion. Die Pipeline basiert auf einem firmeneigenen liposomalen Transportsystem und umfasst insbesondere Anwendungen in den Bereichen Onkologie (schonende...
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Clinical Data Manager
Vor 5 Tagen
Bern, Schweiz Insel Gruppe VollzeitMedical division abdomen and metabolism Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism (UDEM) Research 50 - 60 % | in Bern Entry immediately or upon agreement Temporary with prospect of a permanent position The Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism is committed to per-forming high quality...
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Regulatory Affairs Manager
vor 2 Wochen
Bern, Schweiz LHH VollzeitFür unseren Mandanten, ein global agierendes mittelständisches Unternehmen mit über 20 Jahren Erfahrung in der Pharmabranche, suchen wir zum nächstmöglichen Zeitpunkt einen **Regulatory Affairs Manager (m/w/d)**. Unser Mandant zeichnet sich durch flache Hierarchien, ein familiäres Miteinander und eine täglich gelebte Wertschätzung...
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Vice President, Head of Regulatory Affairs
vor 23 Stunden
Bern, Schweiz NonStop Consulting VollzeitOn behalf of a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition we are currently looking for a Vice President, Head of Regulatory Affairs for their Biosimilars BU. **Activities**: Responsible for directing global regulatory strategies for assigned projects and...
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Manager Quality Assurance and Regulatory Affairs
vor 2 Wochen
Bern, Schweiz Vetoquinol AG Vollzeit**Arbeitspensum: 80-100%** **Ihre Aufgaben**: - Innerhalb eines kleinen Teams sind Sie mitverantwortlich für die GMP Compliance und Zulassungskonformität unserer tiermedizinischen Produkte sowie die GDP Compliance der Lieferkette. - Zudem wirken Sie mit bei allen regulatorischen Zulassungsaufgaben entsprechend den gesetzlichen Richtlinien und den...
Clinical Affairs Manager
vor 2 Wochen
machineMD - Who we are Founded 5 years ago in Bern by an interdisciplinary team with a shared vision for a world where patients receive an accurate, fast, and early diagnosis of brain disorders, machineMD is a rapidly growing Swiss MedTech company focusing on oculometrics. Join machineMD and be part of a dedicated team with focus on the diagnosis and monitoring of neurological disorders through neuro-ophthalmology. Our flagship device, neos, is the world’s first neuro-ophthalmoscope, enabling fast, quantitative, and objective exams using VR and AI-driven eye tracking. Tasks The Role As a Clinical affairs manager at machineMD, you’ll be part of a fast paced and solution oriented interdisciplinary team where communication channels are short and decision rights distributed. You will support the strategic execution of our clinical roadmap, ensure that machineMD’s clinical research projects run smoothly and take responsibility for setting up and managing the investigator initiated research framework. Key Responsibilities - Operational management and oversight of clinical investigations, during set-up, conduct and until archiving; - Submissions, amendments and regulatory reporting to ethics committees and regulatory authorities, including safety reporting, annual reports and other required submissions. - Monitoring of company sponsored clinical investigations - Manage clinical documentation in accordance with ISO 14155, MDR, and FDA requirements and ensuring completeness and maintenance of TMF (Trial Master File) including filing and uploading documents and performing ongoing quality checks/review; - Coordinate data collection and analysis in collaboration with study sites - Review, keep up to date and/or create Standard Operational Procedures (SOPs), Work Instructions and processes; - Support regulatory submissions (e.g., FDA 510(k), CE technical files) - Contribute to publications and scientific presentations - Act as liaison between R&D, Quality, and Commercial teams to integrate clinical insights **Requirements**: - Completed Master’s degree (MSc) in a technical, natural or health science discipline or an equivalent qualification - At least 3 years of experience in the field of clinical trials/investigations, ideally for diagnostic medical devices, Class IIa or Class IIb - Experience with ophthalmology or neurology is a strong asset - Proven track record of clinical trial management, preparation of documentation and submission to competent authorities. - Excellent knowledge of regulatory requirements: MDR (2017/745) and MDCG guidance, Good Clinical Practice ISO 14155, FDA guidelines - Communication: Strong interpersonal skills, with the ability to collaborate effectively with investigators and sponsor representatives. - Open to travel if required (< 10%) - Strong scientific understanding and solid experience in scientific writing and publishing are a plus - Experience in clinical research, risk analysis and clinical study planning in the Medtech industry is a plus - Hands-on mindset, proactive, structured with high level of organizational skills, detail-oriented and collaborative with enthusiasm for interdisciplinary collaboration - Fluent in English, both written and spoken, German and French a plus **Benefits**: - Be part of a fast-growing Medtech startup shaping the future of brain diagnostics - Work alongside top medical experts and innovative minds - International environment with locations in Bern and Boston - Flexible worktime with possibility for home-office (fix in-office day: Mondays) in a company where work-life balance is key to productivity - A strong company culture based on the concept of Conscious leadership and self-leadership, integrating elements of holacracy, encouraging independence, commitment and responsibility
