Head Of Regulatory Affairs
Vor 2 Tagen
2016 certified medical device company and are currently expanding our team. Joining our company you will have the unique chance to support the development of AI medical device software products. As the company is growing and expanding, we also provide a great learning opportunity. Job Description Head of Regulatory Affairs - full-time (f/m/d) contextflow is an award-winning startup developing artificial intelligence-based software applications to support radiologists during their clinical routine. We are an EN ISO 13485:
2016 certified medical device company developing AI-based medical device software that is certified according to the MDR and are striving for international market placement of our products. Currently we have the unique opportunity to join us as Head of Regulatory Affairs where you will have the chance to play a key role during the development of medical device software products and will be responsible for the expansion of our products in our target markets. You will have the opportunity to work across teams to support product development as well as marketing and sales teams in their tasks. As a Head of Regulatory Affairs, you will:
Own / ensure regulatory compliance of our devices, including risk management, post-market surveillance, clinical evaluation, market clearance, product labeling, product registration. Define regulatory strategies for new products to be placed in applicable markets. Own & maintain corresponding processes within our ISO 13485-certified Quality Management System. Support our product development team in the development of AI-based image analysis solutions. Support our marketing team in creating regulatory-compliant sales materials. Requirements What we are looking for:
Experience with regulating / clearing Software as a Medical Device under MDR. Experience with corresponding applicable standards and norms (ISO 13485, ISO 14971, IEC 62304, IEC 62366, ISO 27001, …). Experience with regulating / clearing AI-based image analysis solutions within radiology. Experience with market clearance in the US. Background in IT, Medical Imaging or any other relevant scientific discipline. Ability to work independently. Structured work style and high level of self-motivation. Strong belief in growing together as a team and having empathy for each other. Experience with leading & growing teams. Open to travel on a quarterly/monthly basis. Fluency in English. Bonus Skills:
Experience with ensuring regulatory compliance of agile development processes. Experience with MDSAP. German, Dutch or any Scandinavian language a plus. What you can expect:
You will be part of an interdisciplinary team, characterized by close collaboration and sharing of knowledge across boundaries of individual fields. We are focused on developing cutting-edge deep learning techniques that serve the rapidly-advancing needs of precision medicine and clinical practice. We place a huge emphasis on the well-being of all our team members. We take care and support each other so that we can grow together. We work hard but also enjoy spending time together. Moreover, you will:
Become part of a team of AI medical image processing experts. Thrive in a young, dynamic learning environment where you can grow. Work on the exciting topic of certification of AI software technology. Work directly with the founders and make meaningful contributions to the company’s action and value. Manage your own time via flexible working hours, remote work possible. Founded in 2016, we are one of the leading AI medical imaging startups, having grown to 35 people. To date, we have raised over €15 million from VCs and EU grants and work together with renowned customers across Europe. Join an award-winning team:
EIC Accelerator Equity Program 2023. Winner, European Radiology Most Downloaded Article 2021. WKO Born Global Champions 2021. EIC Acceleratory Grant 2020. Best Healthtech Startup 2019 (Austria) - Central European Startup Awards. Best Pitch 2019 (Healthcare) - Pioneers Festival. Philips HealthWorks 2018 - Chosen as one of 19 participants out of 700+ applications. Digital Innovation Award 2017 - Austrian Federal Ministry of Education, Science and Research. Most Promising Startup 2016 - BCS Search Industry. Science & Business Award 2016 - Rudolf Sallinger Fonds. We are an equal opportunities employer and value diversity Salary negotiable based on experience and know-how. How to apply:
Interested? Send us your CV and your motivational letter with max 1500 characters (~ half a page), letting us know why you would like to join contextflow and how you can best contribute. You may provide links or attachments with information about yourself (LinkedIn, Xing, website, GitHub…). Kindly note that reference letters and contacts may be requested as part of the recruitment process. We look forward to receiving your application #J-18808-Ljbffr
-
Head of Regulatory Affairs
vor 2 Monaten
Wien, Österreich BOEHRINGER Ingelheim RCV GmbH & Co KG Vollzeit**The position**: As of now we are seeking a Head of Regulatory Affairs & Pharmacovigilance for our Animal Health RCV (Regional Center Vienna) department to join at Boehringer Ingelheim´s site in Vienna. In this role you will be responsible for managing the Product Registration Chain, Compliance with all regulatory authorities and Global Regulatory Affairs,...
-
Head Of Regulatory Affairs
Vor 2 Tagen
Wien, Österreich Jobleads Vollzeit € 84.000Head of Regulatory Affairs (m/w/d) Dienstort: | Wien | St. Johann in der Haide | | Vollzeit | Benefits Moderner, attraktiver und innovativer Arbeitsplatz Tolle und angenehme Arbeitsatmosphäre in einem hochmodernen Büro-, Produktions- und Logistikgebäude mit gelebter „Du-Kultur“ RINGANA Competence Development Programm mit internen und externen...
-
Division Head
Vor 2 Tagen
Wien, Österreich Jobleads VollzeitQbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD. Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical...
-
Division Head
Vor 6 Tagen
Wien, Österreich TRIUM Clinical Consulting NV VollzeitQbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD.Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical...
-
Wien . Bezirk (Innere Stadt), Österreich Allergopharma GmbH & Co. KG VollzeitÜberblickBei der Allergopharma GmbH & Co. KG handelt es sich um ein internationales Pharmaunternehmen, das auf die Entwicklung, Herstellung und den Vertrieb von Präparaten zur Diagnose und Therapie allergischer Erkrankungen spezialisiert ist.LönDas Bruttojahresgehalt beträgt circa 120.000 Euro, wozu neben dem Grundgehalt auch eine Weihnachtsgelderfassung...
-
Wien . Bezirk (Innere Stadt), Österreich Allergopharma GmbH & Co. KG VollzeitWir suchen einen erfahrenen Regulatory Affairs Manager, der unsere Abteilung bei Allergopharma GmbH & Co. KG leiten und weiterentwickeln möchte.Über unser UnternehmenAllergopharma ist ein internationales Pharmaunternehmen mit Sitz in Reinbek. Wir sind spezialisiert auf die Entwicklung, Herstellung und den Vertrieb von Präparaten zur Diagnose und Therapie...
-
Associate Director, Regulatory Affairs
Vor 2 Tagen
Wien, Österreich Jobleads VollzeitJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market Surveillance Job Type: Full Time, Permanent Position Locations: Austria, Vienna – Hybrid Remuneration: Attractive salary and package An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and...
-
Junior/professional Group Regulatory Affairs
vor 2 Wochen
Wien, Österreich Raiffeisen Bank International AG Vollzeit-Search by Keyword - Show More Options _ - Loading... _ - Select how often (in days) to receive an alert: _ - Create Alert _ **_Junior/Professional Group Regulatory Affairs Manager - Prudential Regulations (f/m/x) _**: - The Group Supervisory Affairs & Regulatory Governance Unit is a well-established department within the Group Regulatory Affairs division,...
-
Regulatory Affairs Expert
vor 3 Wochen
Wien, Wien, Österreich Contextflow VollzeitCompany OverviewContextflow is an innovative AI medical imaging startup that has gained significant recognition in the industry. Founded in 2016, we have grown to a team of 35 individuals and have received over €15 million in funding from venture capitalists and EU grants.We work closely with renowned customers across Europe and have been recognized for...
-
Associate Director, Regulatory Affairs
vor 3 Wochen
Wien, Österreich Cpl Healthcare VollzeitJob Title: Associate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceJob Type: Full Time, Permanent PositionLocations: Austria, Vienna - HybridRemuneration: Attractive salary and packageAn exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due...
-
Junior Group Regulatory Affairs Manager
vor 6 Monaten
Wien, Österreich Raiffeisen Bank International Vollzeit**Junior Group Regulatory Affairs Manager** **Payments Topic (f/m/x)**: - The Group Supervisory Affairs & Regulatory Governance Unit is a well-established department within the Group Regulatory Affairs division, acts as a regulatory Hub responsible for monitoring EU, international and national regulatory landscape for all regulatory developments which are...
-
Dynamische Leitung für Regulatory Affairs
vor 1 Monat
Wien, Wien, Österreich Talentor Austria GmbH VollzeitUnser Klient ist ein erfolgreiches, pharmazeutisches Unternehmen, das weltweit verschreibungspflichtige Originalpräparate für Fachärzt innen anbietet, weiterentwickelt und über strategische Zukäufe stetig wächst. Über seine Zentrale in Wien wird sein etabliertes Netzwerk zur Herstellung und zum Vertrieb seiner Produkte gesteuert. Das Unternehmen wird...
-
Wien, Wien, Österreich Talentor Austria GmbH VollzeitUnser Kunde ist ein namhaftes pharmazeutisches Unternehmen, das weltweit hochwertige Arzneimittel für Fachärzte entwickelt, produziert und vertreibt. Es verfügt über eine umfassende Erfahrung in der Durchführung klinischer Studien und hat sich auf die Erbringung von hochqualitativen Dienstleistungen spezialisiert.Beschreibung der PositionWir suchen...
-
Wissenschaftliche Führungskraft im Regulatory Affairs
vor 15 Stunden
Wien, Wien, Österreich Talentor Austria GmbH VollzeitBeschreibungUnser Kunde ist ein erfolgreiches, privat geführtes Unternehmen in der Pharmabranche mit einem weltweiten Markenportfolio und einer langjährigen Erfolgsgeschichte. Das Unternehmen ist bekannt für seine Innovation, Qualitätsorientierung und seinen starken Kundenbezug.ZuständigkeitWir suchen eine engagierte, führungserfahrene...
-
Regulatory Affairs Operations Specialist
vor 1 Woche
Wien, Wien, Österreich Boehringer Ingelheim RCV GmbH & Co KG VollzeitBoehringer Ingelheim RCV GmbH & Co KG seeks a highly skilled Regulatory Affairs Operations Manager to join our team in Vienna for a limited contract period of 12 months.About the RoleThe ideal candidate will have proven experience in clinical development, clinical trial applications, and regulatory affairs. They should be able to manage and lead projects...
-
Wien, Wien, Österreich Talentor Austria GmbH VollzeitBeschreibung der StelleWir suchen eine fachkundige Leiterin/Leiter für unser Regulatory Affairs Team in Wien. Als Associate Director Regulatory Affairs werden Sie verantwortlich sein, die regulatorischen Aktivitäten und Projekte zu leiten, das Team zu führen und weiterzuentwickeln, sowie die Geschäftspartner und CROs zu managen.Aufgaben und...
-
Wien, Wien, Österreich Talentor Austria GmbH VollzeitBei Talentor Austria GmbH suchen wir einen erfahrenen Regulatory Affairs Manager, der in einer dynamischen und innovativen Umgebung arbeiten möchte.BeschreibungAls Regulatory Affairs Manager werden Sie verantwortlich sein für die Leitung aller regulatorischer Aktivitäten und ausgewählter RA-Projekte. Dazu gehören die Vorbereitung und Einreichung von...
-
Regulatory Affairs Leiter/in
vor 2 Wochen
Wien, Wien, Österreich Talentor Austria GmbH VollzeitUnsere PositionVon entscheidender Bedeutung für unser Unternehmen ist die Weiterentwicklung seiner Produkte. Als Associate Director Regulatory Affairs in unserem pharmazeutischen Unternehmen werden Sie maßgeblich an diesem Prozess beteiligt.Ihre RolleSicherstellung der Planung, Vorbereitung und Einreichung von nationalen und internationalen...
-
Head, Office of Legal Affairs
vor 13 Stunden
Wien, Österreich OSCE VollzeitBackground: The OSCE has a comprehensive approach to security that encompasses politico-military, economic and environmental, and human aspects. It therefore addresses a wide range of security-related concerns, including arms control, confidence - and security-building measures, human rights, national minorities, democratization, policing strategies,...
-
Wien, Wien, Österreich Cpl Healthcare VollzeitJob TitleAssociate Director, Regulatory Affairs - Medical Device/ Post Market SurveillanceAbout the RoleWe are seeking a highly skilled and experienced Associate Director to lead our Medical Device Regulatory Affairs team. This is an excellent opportunity for a senior professional to take on a challenging role in a growing pharmaceutical company specializing...
