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362 Treffer für Clinical Affairs Jobs
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Schnelle Bewerbung
Zum nächstmöglichen Zeitpunkt suchen wir einen Clinical Research Associate (m/w/d) Clinical Affairs
Zum nächstmöglichen Zeitpunkt suchen wir einen Clinical Research Associate (m/w/d) Clinical Affairs
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Clinical Affairs Specialist (m/w/d)
Clinical Affairs Specialist (m/w/d)
corpuls - GS Elektromedizinische Geräte G. Stemple
Kaufering
Teilweise Home-Office
Anschreiben nicht erforderlich
Berufserfahrung in den relevanten Aufgabenbereichen von Clinical/Medical Affairs
Berufserfahrung in den relevanten Aufgabenbereichen von Clinical/Medical Affairs
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Collaborate with Regulatory, Quality, and Clinical Affairs to ensure traceability and compliance of all diagnostic-related datasets - The ideal candidate brings strong experience in digital pathology operations and data management, along with a practical understanding of clinical development and diagnostic requirements. * Define, implement and monitor end-to-end CP delivery workflows translating research, clinical, and diagnostic needs into practical execution, in collaboration with Quality Management and cross-functional teams, * Drive initiatives to make clinical pathology data analysis-ready for downstream discovery and regulatory use - In this role, you will be instrumental in building the operational and data delivery foundation that connects computational pathology research with clinical and diagnostic impact.
Collaborate with Regulatory, Quality, and Clinical Affairs to ensure traceability and compliance of all diagnostic-related datasets - The ideal candidate brings strong experience in digital pathology operations and data management, along with a practical understanding of clinical development and diagnostic requirements. * Define, implement and monitor end-to-end CP delivery workflows translating research, clinical, and diagnostic needs into practical execution, in collaboration with Quality Management and cross-functional teams, * Drive initiatives to make clinical pathology data analysis-ready for downstream discovery and regulatory use - In this role, you will be instrumental in building the operational and data delivery foundation that connects computational pathology research with clinical and diagnostic impact.
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Werkstudent (m/w/d) Technische Dokumentation
Werkstudent (m/w/d) Technische Dokumentation
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Wiesbaden
Schnelle Bewerbung
Ausarbeitung prozessbegleitender Dokumentation und enge Zusammenarbeit mit internen Schnittstellen, darunter Regulatory Affairs, Product Management, Clinical Affairs und International Registration. Du suchst eine abwechslungsreiche Tätigkeit an der Schnittstelle zwischen Regulatory Affairs und Produktmanagement?
Ausarbeitung prozessbegleitender Dokumentation und enge Zusammenarbeit mit internen Schnittstellen, darunter Regulatory Affairs, Product Management, Clinical Affairs und International Registration. Du suchst eine abwechslungsreiche Tätigkeit an der Schnittstelle zwischen Regulatory Affairs und Produktmanagement?
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Schnelle Bewerbung
Enge Zusammenarbeit mit dem Entwicklungsteam und anderen Fachbereichen wie z.B. Qualitätsmanagement und Clinical Affairs
Enge Zusammenarbeit mit dem Entwicklungsteam und anderen Fachbereichen wie z.B. Qualitätsmanagement und Clinical Affairs
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Enge Zusammenarbeit mit internen Bereichen (R&D, Projektleitung, Produktmanagement, Marketing Communications, Clinical Affairs, internationalen RA Ansprechpartner/innen in den jeweiligen Märkten) sowie mit externen Behörden und Partnern * Die Optimierung von globalen standortübergreifenden Regulatory Affairs Prozessen vorantreiben * Aktive und umfangreiche Berufsbezogene Erfahrung im Bereich Regulatory Affairs bei Softwareprodukten in der Medizintechnik oder vergleichbare Berufserfahrung
Enge Zusammenarbeit mit internen Bereichen (R&D, Projektleitung, Produktmanagement, Marketing Communications, Clinical Affairs, internationalen RA Ansprechpartner/innen in den jeweiligen Märkten) sowie mit externen Behörden und Partnern * Die Optimierung von globalen standortübergreifenden Regulatory Affairs Prozessen vorantreiben * Aktive und umfangreiche Berufsbezogene Erfahrung im Bereich Regulatory Affairs bei Softwareprodukten in der Medizintechnik oder vergleichbare Berufserfahrung
Post Market Surveillance Manager (m/w/d) - Teilzeit
Post Market Surveillance Manager (m/w/d) - Teilzeit
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Wiesbaden
Teilweise Home-Office
Zur Verstärkung unseres Teams im Bereich Clinical Affairs & Risk Management suchen wir zum nächstmöglichen Zeitpunkt eine engagierte Persönlichkeit als Post-Market-Surveillance Manager (m/w/d). * Eigenverantwortliche Steuerung und Koordination aller Post-Market-Surveillance-(PMS)-Aktivitäten im Bereich Clinical Affairs & Risk Management
Zur Verstärkung unseres Teams im Bereich Clinical Affairs & Risk Management suchen wir zum nächstmöglichen Zeitpunkt eine engagierte Persönlichkeit als Post-Market-Surveillance Manager (m/w/d). * Eigenverantwortliche Steuerung und Koordination aller Post-Market-Surveillance-(PMS)-Aktivitäten im Bereich Clinical Affairs & Risk Management
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Medical Writer/Consultant (m/w/d) – Clinical Affairs Medizinprodukte
Medical Writer/Consultant (m/w/d) – Clinical Affairs Medizinprodukte
IASON consulting - Inh. Dr Karin Jochims
Niederzier
Schnelle Bewerbung
StellenbeschreibungZur Verstärkung unseres Teams suchen wir eine/n wissenschaftliche/n Mitarbeiter/in (m/w/d) im Bereich Medical Writing für Clinical Affairs Medizinprodukte. - Verfassen weiterer wissenschaftlich fundierter Dokumente für Clinical Affairs, z. B. Literature Reviews, Post-Market Surveillance (PMS) und Post-Market Clinical Follow-up (PMCF)-Dokumente. - Erstellung, Überarbeitung und Pflege klinischer Bewertungen (Clinical Evaluation Reports, CERs) gemäß MDR und relevanter Leitlinien (MEDDEV 2.7/1 Rev. Medical Writer Clinical- Mitarbeit in einem spezialisierten, wachsenden Beratungsunternehmen mit hoher fachlicher Expertise.
StellenbeschreibungZur Verstärkung unseres Teams suchen wir eine/n wissenschaftliche/n Mitarbeiter/in (m/w/d) im Bereich Medical Writing für Clinical Affairs Medizinprodukte. - Verfassen weiterer wissenschaftlich fundierter Dokumente für Clinical Affairs, z. B. Literature Reviews, Post-Market Surveillance (PMS) und Post-Market Clinical Follow-up (PMCF)-Dokumente. - Erstellung, Überarbeitung und Pflege klinischer Bewertungen (Clinical Evaluation Reports, CERs) gemäß MDR und relevanter Leitlinien (MEDDEV 2.7/1 Rev. Medical Writer Clinical- Mitarbeit in einem spezialisierten, wachsenden Beratungsunternehmen mit hoher fachlicher Expertise.
Schnelle Bewerbung
Partner closely with Medical Affairs, Clinical, and Commercial on segmentation, KOL engagement pathways, and strategic partnerships within the German cardiology community. * Lead the development and continuous evolution of the German TMTT marketing strategy, ensuring alignment with the European vision while tailoring approaches to local market dynamics, regulatory frameworks, and unmet clinical needs. * Understand customer and commercial teams' needs through regular field presence, localize marketing assets, and develop thorough knowledge of therapy, clinical data and competitive landscape * Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks
Partner closely with Medical Affairs, Clinical, and Commercial on segmentation, KOL engagement pathways, and strategic partnerships within the German cardiology community. * Lead the development and continuous evolution of the German TMTT marketing strategy, ensuring alignment with the European vision while tailoring approaches to local market dynamics, regulatory frameworks, and unmet clinical needs. * Understand customer and commercial teams' needs through regular field presence, localize marketing assets, and develop thorough knowledge of therapy, clinical data and competitive landscape * Possess strong clinical knowledge, experience and knowledge of the clinical areas where Edwards' products are used or intended to be used, understand the purchasing process and challenges for product adoption in complex healthcare networks
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Field Clinical Specialist Münster - Hannover
Field Clinical Specialist Münster - Hannover
Edwards Lifesciences GmbH
Bielefeld, Münster, Hannover
Teilweise Home-Office
Schnelle Bewerbung
This role will collaborate with multiple departments including Sales, Clinical Affairs, Marketing, Quality, Regulatory, and Education. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Field Clinical Specialists will provide guidance on the use of the device, thereby enabling physicians and staff to reach expert proficiency and deliver positive patient outcomes. After extensive training, a Field Clinical Specialist will travel frequently within an assigned territory, clinically training customers on the THV technology. * Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs
This role will collaborate with multiple departments including Sales, Clinical Affairs, Marketing, Quality, Regulatory, and Education. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Field Clinical Specialists will provide guidance on the use of the device, thereby enabling physicians and staff to reach expert proficiency and deliver positive patient outcomes. After extensive training, a Field Clinical Specialist will travel frequently within an assigned territory, clinically training customers on the THV technology. * Working independently in the areas of valve crimping, case management, pre-case planning, post-case management, 3 Mensio management, Therapy Awareness program management and clinical education programs
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Für den Bereich Clinical Affairs suchen wir einen Studentischen Mitarbeiter Data Management m/w/d - Zur Verstärkung unseres Clinical Affairs Teams suchen wir dich - eine wissbegierige, strukturierte und motivierte Persönlichkeit mit Freude an Daten, Analyse und medizinischer Forschung.
Für den Bereich Clinical Affairs suchen wir einen Studentischen Mitarbeiter Data Management m/w/d - Zur Verstärkung unseres Clinical Affairs Teams suchen wir dich - eine wissbegierige, strukturierte und motivierte Persönlichkeit mit Freude an Daten, Analyse und medizinischer Forschung.
Die Funktion arbeitet eng mit anderen CTCO-Funktionen, Clinical Development und Medical Affairs über mehrere Indikationen und Abteilungen hinweg zusammen, um das vielfältige Zelltherapie-Portfolio von AstraZeneca zu fördern. * Koordination der Lieferung über CTCO-Abteilungen, Clinical Development, Medical Affairs, Supply/Logistik, Patient Operations und Country Operations, um eine schnelle, zuverlässige Unterstützung für und Studienzentren sicherzustellen. Als Field Clinical Advisor (FCA) (m/w/) - Cell Therapy sind Sie Teil des globalen Cell Therapy Clinical Operations Teams. Wenn Sie jetzt denken „Hier ist meine Zukunft!", dann freuen wir uns auf Ihre Bewerbung als Field Clinical Advisor (m/w/d) Cell Therapy. * Systematische Bewertung von Bildungsbedarfen über alle Sites hinweg, Bereitstellung von fortgeschrittenen Protokollschulungen und Eskalation von Mustern an das globale ...
Die Funktion arbeitet eng mit anderen CTCO-Funktionen, Clinical Development und Medical Affairs über mehrere Indikationen und Abteilungen hinweg zusammen, um das vielfältige Zelltherapie-Portfolio von AstraZeneca zu fördern. * Koordination der Lieferung über CTCO-Abteilungen, Clinical Development, Medical Affairs, Supply/Logistik, Patient Operations und Country Operations, um eine schnelle, zuverlässige Unterstützung für und Studienzentren sicherzustellen. Als Field Clinical Advisor (FCA) (m/w/) - Cell Therapy sind Sie Teil des globalen Cell Therapy Clinical Operations Teams. Wenn Sie jetzt denken „Hier ist meine Zukunft!", dann freuen wir uns auf Ihre Bewerbung als Field Clinical Advisor (m/w/d) Cell Therapy. * Systematische Bewertung von Bildungsbedarfen über alle Sites hinweg, Bereitstellung von fortgeschrittenen Protokollschulungen und Eskalation von Mustern an das globale ...
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To enlarge our Clinical Regulatory Affairs Team we are looking as soon as possible for a * Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest. * Give insights into clinical data sets and evidence for our company's products to internal stakeholders. * Assess clinical study ideas and initiatives as well as act as for the respective internal approval process. * Keep record of clinical initiatives, grants and data collections in the field. * Define data endpoints and sample sizes (together with clinical evaluation team and support of biostatistics) for data collections, studies and clinical initiatives. * Author and review study synopses and clinical trial protocols, regulatory documents, and study-related publications for clinical initiatives and grants.
To enlarge our Clinical Regulatory Affairs Team we are looking as soon as possible for a * Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest. * Give insights into clinical data sets and evidence for our company's products to internal stakeholders. * Assess clinical study ideas and initiatives as well as act as for the respective internal approval process. * Keep record of clinical initiatives, grants and data collections in the field. * Define data endpoints and sample sizes (together with clinical evaluation team and support of biostatistics) for data collections, studies and clinical initiatives. * Author and review study synopses and clinical trial protocols, regulatory documents, and study-related publications for clinical initiatives and grants.
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Schnelle Bewerbung
Du arbeitest eng mit Qualitätswesen, Beschaffung, Fertigung, Regulatory Affairs und Clinical Affairs zusammen.
Du arbeitest eng mit Qualitätswesen, Beschaffung, Fertigung, Regulatory Affairs und Clinical Affairs zusammen.
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The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
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Schnelle Bewerbung
Mindestens 5 Jahre einschlägige Berufserfahrung im Bereich Medical Affairs, Clinical Research in der Medizintechnikbranche (Medizinprodukte) oder bei Auftragsforschungsinstituten, idealerweise im Bereich der Wundversorgung. Als Medical Affairs Manager (m/w/d) wirst du eine entscheidende Rolle auf unserem Weg zum führenden Anbieter von Add-on Wundtherapien spielen. * Prozessoptimierung: Die Anpassung und Verbesserung von Medical Affairs Prozessen liegen in deinem Aufgabenbereich. * Unterstützung von Regulierungsfragen: Du unterstützt das Regulatory Affairs Team bei der Inverkehrbringung von Medizinprodukten und der klinischen Bewertung.
Mindestens 5 Jahre einschlägige Berufserfahrung im Bereich Medical Affairs, Clinical Research in der Medizintechnikbranche (Medizinprodukte) oder bei Auftragsforschungsinstituten, idealerweise im Bereich der Wundversorgung. Als Medical Affairs Manager (m/w/d) wirst du eine entscheidende Rolle auf unserem Weg zum führenden Anbieter von Add-on Wundtherapien spielen. * Prozessoptimierung: Die Anpassung und Verbesserung von Medical Affairs Prozessen liegen in deinem Aufgabenbereich. * Unterstützung von Regulierungsfragen: Du unterstützt das Regulatory Affairs Team bei der Inverkehrbringung von Medizinprodukten und der klinischen Bewertung.
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We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. For one of our sponsors we are currently recruiting for a contract specialist / financial clinical operations specialist to join the team. * Excellent understanding of clinical trial process across Phases II-IV and ICH GCP * Good understanding clinical protocols and associated study specifications.
We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. For one of our sponsors we are currently recruiting for a contract specialist / financial clinical operations specialist to join the team. * Excellent understanding of clinical trial process across Phases II-IV and ICH GCP * Good understanding clinical protocols and associated study specifications.
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The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
The Medical Affairs (Clinical Affairs) Manager is held responsible for keeping a product or product group compliant with regulations and guidelines. * Focusing on Medical Affairs related processes such as PMS, PMCF, Clinical Evaluation, Risk Management, Change Management and Nonconformance/Corrective and Preventive Action to ensure required input and output documentation * Collaboration with Regulatory Affairs, Product Management, R&D, and/or external service providers to support PMS, PMCF, Clinical Evaluation documentation - The employee ensures the proper implementation of procedures that demonstrate the conformity of medical devices with the relevant clinical performance and safety requirements as well as the documentation required by MDR/MEDDEV. * Provide and update regulatory documentation, such as Post Market Surveillance (PMS) Plans, PMS Reports and/or Periodic Safety Update Reports ...
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Senior Clinical Trial Physician (m|f|d)
Senior Clinical Trial Physician (m|f|d)
Miltenyi Biotec B.V. & Co. KG
Bergisch Gladbach
Teilweise Home-Office
In addition, you will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and external partners, to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and - We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As a Senior Clinical Trial Physician, you will play a pivotal role in providing medical leadership and scientific expertise to ensure ...
In addition, you will work closely with cross-functional teams, including Clinical Operations, Regulatory Affairs, Biostatistics, and external partners, to ensure the smooth execution of clinical programs and foster a culture of scientific excellence and - We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. As a Senior Clinical Trial Physician, you will play a pivotal role in providing medical leadership and scientific expertise to ensure ...
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ulrich GmbH & Co. KG * Ulm * Berufseinstieg/Trainee, Feste Anstellung * Vollzeit - Job-Nummer: req304 - Bei ulrich medical begeistern wir uns für die Gesundheit und die Lebensqualität von Menschen. Teilen Sie unsere Leidenschaft für Medizintechnik und widmen Ihre Energie gerne der Entwicklung und Vermarktung innovativer Produkte? Dann kommen Sie zu ulrich medical. Es erwartet Sie ein Unternehmen, in dem der Mensch im Mittelpunkt steht und Teamgeist gelebt wird sowie ein dynamisches Umfeld mit vielen Möglichkeiten, sich beruflich und persönlich weiterzuentwickeln. Hier sind Sie gefragt * In Ihrer Rolle als Spezialist (m/w/d) für Zulassungen neuer Medizinprodukte arbeiten Sie eng mit der Entwicklungsabteilung und dem Produktmanagement zusammen * Sie erarbeiten die Zulassungsvoraussetzungen sowie -strategien für unsere Medizinprodukte, vorrangig in der EU und den USA
ulrich GmbH & Co. KG * Ulm * Berufseinstieg/Trainee, Feste Anstellung * Vollzeit - Job-Nummer: req304 - Bei ulrich medical begeistern wir uns für die Gesundheit und die Lebensqualität von Menschen. Teilen Sie unsere Leidenschaft für Medizintechnik und widmen Ihre Energie gerne der Entwicklung und Vermarktung innovativer Produkte? Dann kommen Sie zu ulrich medical. Es erwartet Sie ein Unternehmen, in dem der Mensch im Mittelpunkt steht und Teamgeist gelebt wird sowie ein dynamisches Umfeld mit vielen Möglichkeiten, sich beruflich und persönlich weiterzuentwickeln. Hier sind Sie gefragt * In Ihrer Rolle als Spezialist (m/w/d) für Zulassungen neuer Medizinprodukte arbeiten Sie eng mit der Entwicklungsabteilung und dem Produktmanagement zusammen * Sie erarbeiten die Zulassungsvoraussetzungen sowie -strategien für unsere Medizinprodukte, vorrangig in der EU und den USA
Noch nichts dabei? Es gibt 341 weitere Jobs, die zu deiner Suche passen könnten
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Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d)
Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d)
Lohmann & Rauscher GmbH & Co. KG
Neuwied
Wir hätten Sie gerne in unserem Team als Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d) Quality and Regulatory Affairs
Wir hätten Sie gerne in unserem Team als Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d) Quality and Regulatory Affairs
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Field Clinical Specialist Central Lower Saxony - Nurse Biomedical APM (m/w/d)
Field Clinical Specialist Central Lower Saxony - Nurse Biomedical APM (m/w/d)
Becton Dickinson
Nordrhein-Westfalen
BD Advanced Patient Monitoring is a global in advanced monitoring solutions that expands BD's portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline. Scale up clinical programs in other sites by sharing problem statement, solution and outcome * Support Regulatory Affairs dept. on the registration of the products * Experience in clinical support with medical devices and/or clinical experience Required
BD Advanced Patient Monitoring is a global in advanced monitoring solutions that expands BD's portfolio of smart connected care solutions with its growing set of leading monitoring technologies, advanced AI-enabled clinical decision tools and robust innovation pipeline. Scale up clinical programs in other sites by sharing problem statement, solution and outcome * Support Regulatory Affairs dept. on the registration of the products * Experience in clinical support with medical devices and/or clinical experience Required
NEU
Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d)
Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d)
Lohmann & Rauscher GmbH & Co. KG
Neuwied
Wir hätten Sie gerne in unserem Team als Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d) Quality & Regulatory Affairs | befristet auf 2 Jahre
Wir hätten Sie gerne in unserem Team als Regulatory Affairs Manager Clinical & Biological Evaluation (m/w/d) Quality & Regulatory Affairs | befristet auf 2 Jahre
Schnelle Bewerbung
As the Head Regulatory affairs and of Quality Management, you will be an integral part of supervising the regulatory and quality matters at Medicaroid hinotoriTM robotic surgery system. * Prepare pre/post market reports / technical and clinical documentation per the requirements of key regulatory agencies (e.g. Notified Body, Competent Authorities and other regulatory authorities in the EMEA region). * Take accountability, lead and manage the quality and regulatory affairs team, ensuring drive, high quality output, wellbeing and development of the * Deep knowledge on relevant regulatory requirements such as GCP (Good Clinical Practice), ISO 14155, MDR (Medical Device Regulation 2017/745), MEDDEV 2.7/1 rev.4 and ISO 13485
As the Head Regulatory affairs and of Quality Management, you will be an integral part of supervising the regulatory and quality matters at Medicaroid hinotoriTM robotic surgery system. * Prepare pre/post market reports / technical and clinical documentation per the requirements of key regulatory agencies (e.g. Notified Body, Competent Authorities and other regulatory authorities in the EMEA region). * Take accountability, lead and manage the quality and regulatory affairs team, ensuring drive, high quality output, wellbeing and development of the * Deep knowledge on relevant regulatory requirements such as GCP (Good Clinical Practice), ISO 14155, MDR (Medical Device Regulation 2017/745), MEDDEV 2.7/1 rev.4 and ISO 13485
NEU