(Senior) Regulatory Affairs Compliance Manager (m/w/d)

Farkas Kiss Endre legjobb állása Croma-Pharma Ges. m.b.H

info@cromapharma.com;complaint@croma.at;office@croma.at

Bewerbung fur Team Lead Life Cycle Management - Manufacturing Science & Validation Engineering (m/w/d)

Levél szövege

Lieber Croma-Pharma Ges. m.b.H!

Ich möchte mich bei Ihrem Unternehmen als (Senior) Regulatory Affairs Compliance Manager (m/w/d) bewerben. 
Ich bin ein Fullstack-Entwickler, bei dem ich meine 10-jährige Erfahrung mit verschiedenen Technologien einsetzen kann.

Ich habe meinen Lebenslauf an diese E-Mail angehängt.

Wir freuen uns darauf, von Ihnen zu hören!


Endre Farkas Kiss "Sodika"
Java and PHP Fullstack Developer, Nudist, Vlogger

https://www.linkedin.com/in/farkas-kiss-63bb9210a
https://sodika.org

Álláshirdetés szövege

(Senior) Regulatory Affairs Compliance Manager (m/w/d)CROMA-PHARMA is an internationally active, family-owned pharmaceutical Company with its headquarter in Leobendorf, Korneuburg district, in the north of Vienna. Many years of experience in the manufacturing of products based on hyaluronic acid and a unique level of expertise in the field of aesthetic medicine have made CROMA-PHARMA a globally renowned specialist in the dynamic and versatile business of anti-aging.Regulatory labelling is the department in CROMA responsible for the administration, translation and publication of product related labels such as instructions for use and folding box texts. Our product portfolio comprises cosmetic products, medical devices and drug products distributed in more than 60 countries of the world. Regulatory labelling plays the key role in the life cycle of our product texts and acts as central coordination unit between translation offices and internal departments.We are searching for applicants who want to make a sustainable contribution to our success as a family- run Austrian company.We are expanding our Regulatory Affairs Development department and therefore looking for a (Senior) Regulatory Affairs Compliance Manager. Ihre AufgabenPlanning, preparation and submission of regulatory projects regarding MDR 2017/745 Communication with notified body and authorities within Europe but also with other departments including R&D Regulatory release of medical device artwork and labels Cross functional team member for MDR initial submissions and lifecycle projects Implementation of VEEVA regulatory modul Active input for US registrations, PMA writing and cooperation with US partners Regulatory input to risk management Ihr ProfilScientific education or similar with at least 5 years of working experience in Regulatory Affairs for medical devices Drugs experience is an advantage Team player with the ability to work with and adhere to timelines High degree in self organization Self-motivated, with a 'can-do' attitude Excellent command of English and German (written / spoken) Knowledge of MDR 2017/745, ISO standards, Common Specifications and MDCGs Knowledge of UDI requirements for single devices and procedure packs Knowledge of EUDAMED Knowledge of US requirements is an advantage Knowledge of differences between medical devices in Europe and US is an absolute plus MS Office knowledge is required (MS Teams, MS Word, Excel, PowerPoint, Outlook, Sharepoint) Experience with VEEVA Wir bietenWe offer a varied work in a rapidly expanding company with diverse development opportunities and company benefits, as well as flexible working hours and home office. If you want to become part of a dynamic team, we look forward to meeting you! For this position, a salary of EUR 49.804,58 (full-time, 38h) applies gross p. a. Willingness to overpayment exists and depends on the specific qualification and experience. Jetzt bewerben