Aktuelle Jobs im Zusammenhang mit Assistance (M/F/d) Regulatory Affairs - Hamburg - Alfred E. Tiefenbacher GmbH & Co. KG
-
Regulatory Affairs Specialist
vor 2 Wochen
Hamburg, Hamburg, Deutschland Sysmex Europe Haematology Vollzeit 55.000 € - 75.000 € pro JahrAre 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...
-
Working Student
Vor 6 Tagen
Hamburg, Deutschland Olympus Europa SE & Co. KG (OEKG) Vollzeit**Responsibilities**: - As Working Student (M/F/d) you assist in the preparation, review, and organization of regulatory documents required for submissions, including technical files, product registration dossiers, and labeling. - You conduct research on regulatory requirements and standards for medical devices in different markets, Summarize and report...
-
Regulatory Affairs Specialist
vor 2 Wochen
Hamburg, Deutschland Sysmex Europe SE Vollzeit 50.000 € - 80.000 € pro JahrAre 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...
-
Team Assistant
vor 1 Tag
Hamburg, Deutschland Olympus Europa SE & Co. KG Vollzeit**Responsibilities**: - Responsible for regulatory affairs activities to assist in regulatory submission (new registrations, renewals and change registrations) - Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards - Assist in creation and maintenance of regulatory files - Write, analyze and edit technical...
-
Mitarbeiter F&e
Vor 6 Tagen
Hamburg, Deutschland hanfried Personaldienstleistungen GmbH VollzeitFür unseren Kunden, ein international agierendes Industrieunternehmen, suchen wir zur Unterstützung des bestehenden Teams am Standort Hamburg einen **Mitarbeiter F&E (m/w/d) Regulatory Affairs** **Ihre Aufgaben**: - Pflegen von Datenbanken - Erstellen von Sicherheitsdatenblättern - Durchführen von PCN-, und SCIP Meldungen - Kontrollieren von...
-
Trainee (M/w/d) Regulatory Affairs
vor 2 Wochen
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...
-
Hamburg, Deutschland Nordex SE Vollzeit**Intern (M/F/d) Regulatory Affairs / Data Protection**: - REQUISITION ID: 10268 - LOCATION: Hamburg, DE, 22419 - DEPARTMENT: Legal / Compliance / Security Would you like to work in an international, dynamic environment within interdisciplinary teams? Are you looking for an opportunity to gain experience in a motivated in-house legal department...
-
Werkstudent (M/w/d) Regulatory Affairs
vor 1 Woche
Hamburg, Deutschland MedSkin Solutions Dr. Suwelack AG VollzeitHamburg - ab sofortWir sind ein global agierendes, mittelständisches Life-Science-Unternehmen mit Schwerpunkt auf Hautpflege - und Medizinprodukten. In unserem Hamburger Büro laufen die Fäden unserer internationalen Aktivitäten im Bereich SkinCare und MedCare zusammen. In unserem Technologiezentrum im Münsterland produzieren wir unsere exklusiven...
-
Hamburg, Deutschland SciPro VollzeitRegulatory Manager CMC (m/w/d) || Pharma || Vertragsart: Vollzeit In dieser Rolle übernehmen Sie die regulatorische Verantwortung für internationale Projekte mit Schwerpunkt auf den Märkten der EU und der USA. Sicherstellung der Einhaltung aktueller nationaler und internationaler Richtlinien Abgeschlossenes naturwissenschaftliches Studium (z. B....
-
Senior Regulatory Affairs Manager
Vor 4 Tagen
Hamburg, Deutschland APRIORI - business solutions AG VollzeitMein Kunde ist ein international tätiges Unternehmen mit Fokus auf Diagnostik. Zur Verstärkung des Regulatory Affairs Teams suche ich im Auftrag zum nächstmöglichen Zeitpunkt einen Senior Regulatory Affairs Manager (m/w/d) im Bereich der internationalen Zulassung.Ihre BenefitsHoher Home-Office AnteilFlexible ArbeitszeitenGesundheits- und...
Assistance (M/F/d) Regulatory Affairs
vor 2 Wochen
As 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 marketing authorisation documents.
Being involved in the preparation and implementation of EU-wide marketing authorisation procedures (MRP/DCP, CP) and variations.
Working together with the Regulatory Affairs Manager regarding the support of our customers in the submission of worldwide marketing authorisation procedures and variations.
Correspondence with customers and authorities.
Entering documents into our eCTD/document management system and maintaining data in the regulatory database.
Filing, archiving, electronic submission.
A convincing background
Education as a PTA, medical documentalist or a comparable qualification
Work experience in the pharmaceutical industry would be desirable
Strong communication skills and solution-oriented way of thinking, ability to deal confidently with people from different backgrounds and culture
Very good analytical skills, highest standards for the own work and the ability not to lose head or sense of humor even in hectic time
High degree of commitment, sense of responsibility and assertivenes
Very good German and English language skills as well as the confident handling of MS Office complete your profile
You are interested in our company and the position we can offer you?
The position will be filled by our HR Business Partner Marie-Theres Blumers.
We look forward to hearing from you
