Director Quality and Regulatory Affairs
Vor 2 Tagen
As the Director Quality and Regulatory Affairs (M/F/d) you support business units and functions in creation, implementation and maintenance of processes and related documented information. Tasks As the Director Quality and Regulatory Affairs (m/w/d) you support business units and functions in creation, implementation and maintenance of processes and related documented information. - You are accountable for the effectiveness of the quality management system and corresponding certifications for the EMEA sales organisations. - You will be responsible for regulatory compliance - You will be responsible for product registration in EMEA countries - You are in charge of the implementation of Field Safety Corrective Actions in the EMEA region - You ensure post market surveillance obligations are fulfilled according to the relevant regulations - You will be leading a team of 4 - You need to be based in the Hamburg office **Requirements**: - You have a university degree or similar qualification - You describe yourself as an experienced QMRA Lead - You have a proven knowledge of ISO 9001:2015 / ISO 13485:2016 and IVDR - Ideally you have a background knowledge of Laser and X-Ray regulations - You bring a business driven attitude - Your communication skills are excellent and you are able to effectively communicate across all levels of the EMEA organization and work productively with others in a team environment - You are fluent in English and German language. Further languages skills are a plus - Risk management knowledge is a plus - You need to be based in Hamburg and will travel to other business locations on a constant basis (< 25%) **Benefits**: - Flexible working hours - 30 days of holiday per year - 13,5 salaries a year - Modern office and inspiring working environment - Subsidized meals in the neighborhood of our office (Stadtküche) - Public transport ticket (100% subsidized) or free parking space - Bike leasing - Subsidy fitness first gym - Employee Assistance Program to support your health, mental and emotional well-being - Comprehensive company pension scheme - Joint company events and activities
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Quality and Regulatory Affairs Manager
vor 2 Wochen
Hamburg, Hamburg, Deutschland Life Science Nord Management GmbH Vollzeit 60.000 € - 100.000 € pro JahrQuality and Regulatory Affairs Manager (m/f/d) – Medical DevicesLocation: Hamburg or remoteWho we areLITERO GmbH is a specialized consulting company supporting medical device manufacturers in meeting global quality and regulatory requirements. Our team provides expert guidance in quality management, regulatory compliance, and clinical affairs according to...
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Regulatory Affairs Specialist
Vor 7 Tagen
Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit**Responsibilities**: - Contact point for regulatory requirements for the market access in the EU, EFTA and Europe - Registration support in EU, EFTA and Europe - Regulatory consultant in the launch of new products - Regulatory assessment for Product launches - Ensuring regulatory compliance in EU - Execute regulatory related projects in EMEA Your...
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Trainee (M/w/d) Regulatory Affairs
Vor 2 Tagen
Hamburg, Deutschland Eppendorf VollzeitIhre Herausforderungen - Sie lernen in unserem 24-monatigen Traineeprogramm die gesamten regulatorischen Anforderungen in dem breiten Spektrum des Qualitätsmanagements kennen. Hierbei werden Sie in unserem Hauptsitz in Hamburg neben dem Bereich Regulatory Affairs und Qualitätsmanagement bis zu drei Schnittstellenabteilungen kennen. Dies umfasst das...
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Working Student
Vor 2 Tagen
Hamburg, Deutschland EVIDENT Europe GmbH VollzeitAufgaben - Coordination of regulatory activities to collect registration information from distributors - Creating and issuing of Confirmation of conformance on customers demand - Creating and providing of documents for local registration within EMEA region - Support Head of Quality and Regulatory Affairs - Development and writing of SOP for RA topics -...
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Hamburg, Deutschland D.Med Consulting GmbH VollzeitYour responsibilities: Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes Creating, reviewing, and maintaining high-quality technical documentation in compliance with MDR, IVDR, and other relevant standards Developing and managing market...
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Regulatory Affairs Adviser
Vor 7 Tagen
Hamburg, Deutschland Shell Vollzeit**The Role**: Are you a strategic thinker and that would like to learn about trading, regulation and market design? If so, we have the role just for you, in either London or Hamburg to kick start your career in the energy sector. **Where you fit in** The EU and German regulatory frameworks for gas are rapidly evolving in response to the challenging energy...
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Regulatory Affairs Specialist
vor 2 Wochen
Hamburg, Hamburg, Deutschland SymBio. Vollzeit 36.000 € - 42.000 € pro JahrRegulatory Affairs Specialist (w/m/d) – Medizintechnik – HamburgFür ein international tätiges Medizintechnikunternehmen mit Sitz in Hamburg, suche ich zum nächstmöglichen Zeitpunkt einen Regulatory Affairs Specialist (m/w/d) in unbefristeter Festanstellung.Ihre Aufgaben:Erstellung und Pflege der technischen Dokumentation für Medizinprodukte nach...
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Regulatory Affairs Manager
vor 1 Woche
Hamburg, Hamburg, Deutschland Real VollzeitRegulatory Affairs Manager (m/w/d)Derzeit suche ich für unseren Kunden, ein innovatives Medizintechnikunternehmen im Großraum Hamburg, einen Regulatory Affairs Manager (m/w/d). Werden Sie Teil eines zukunftsorientierten Unternehmens in unbefristeter Festanstellung und gestalten Sie aktiv die regulatorische Zukunft mit.Ihre Aufgaben:Verantwortung für...
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Assistance (M/F/d) Regulatory Affairs
Vor 2 Tagen
Hamburg, Deutschland Alfred E. Tiefenbacher GmbH & Co. KG VollzeitAs Assistance Regulatory Affairs you will work together with the Regulatory Affairs Manager on different regulatory issues to support our clients in the best possible way. You will work in an international environment with a focus on administration and preparation of chemical-pharmaceutical documentations. A challenging task Supporting the preparation of...
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Regulatory Affairs Specialist
vor 2 Wochen
Hamburg, Deutschland Sysmex Europe SE VollzeitAre you looking for more than just a job, for something truly meaningful and rewarding? Then Sysmex Europe SE is the place for you. As the regional headquarters for the EMEA (Europe, Middle East and Africa) region, our company is dedicated to providing essential products that help people worldwide on their healthcare journey. If this opportunity appeals to...
