(Senior) Regulatory Affairs Manager (m/f/d) - Medical Devices EU

60318 Frankfurt am Main, Frankfurt am Main
09.10.2020

Daten dieser Anzeige

Job-ID: 017300088
(Senior) Regulatory Affairs Manager (m/f/d) - Medical Devices EU

Merz Aesthetics

Germany

https://merzpharma-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.jobinfo&jobid=1064&company_id=30120&version=1&source=ONLINE&jobOwner=992452&aid=1

You prepare and submit applications for conformity assessment/clinical trials of non-active implantable medical devices in the EU and respond to questions from Notified Bodies and Competent Authorities, in a timely and accurate manner You are responsible for the compilation and update of CE-dossiers for registrations/clinical trial applications (CTA), advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data in EU and assessment of dossiers of third parties You prepare and update product's core labelling according to available data and relevant guidelines You conduct the maintenance/Life-Cycle Management of the CE mark (preparation and submissions of applications for renewals, change notifications, annual updates etc.) in due time You assess proposed changes by the production centers, marketing departments etc. from a regulatory point of view You coordinate regulatory projects and interact with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues You develop regulatory strategies, participate in project teams and act as contact person with regards to regulatory requirements You conduct Due Diligences for established products with regards to regulatory aspects

  Our leading position in the global market in the areas of Aesthetics, Therapeutics, and Consumer Care is the result of our innovative spirit and the commitment of our staff. Our highly attractive portfolio, a strong strategic focus, and dynamic characterize us as a company that is heading towards long-term growth and success. Do you share our enthusiasm for customer oriented work and are willing to take up the task of continuing to write our success story? Then join Merz Aesthetics, a division of Merz Pharmaceuticals GmbH, as      (Senior) Regulatory Affairs Manager (m/f/d) Medical Devices EU      THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:   You prepare and  submit applications for conformity assessment/clinical trials of non-active implantable medical devices in the EU and  respond to questions from Notified Bodies and Competent Authorities, in a timely and accurate manner You are responsible for the compilation and update of CE-dossiers for registrations/clinical trial applications (CTA), advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data in EU and assessment of dossiers of third parties You prepare and update product's core labelling according to available data and relevant guidelines You conduct the maintenance/Life-Cycle Management of the CE mark (preparation and submissions of applications for renewals, change notifications, annual updates etc.) in due time You assess proposed changes by the production centers, marketing departments etc. from a regulatory point of view You coordinate regulatory projects and interact with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues You develop regulatory strategies, participate in project teams and act as contact person with regards to regulatory requirements You conduct Due Diligences for established products with regards to regulatory aspects   WHAT WE EXPECT FROM YOU:    Natural scientific background (pharmacist, biologist or chemist), approbation, diploma, master degree or PhD  Approx. 1-3 years of experience in EU regulatory affairs for medical devices, combined with profound knowledge of the European regulatory landscape Experience with energy based devices is a plus Self-confident manner combined with strong communication skills - also fluent in Business English, further language skills would be preferable  Your skills include strategic and analytical thinking, a highly structured way of working and networking abilities        WHAT YOU CAN EXPECT FROM US:   Meaningful work and exciting projects from day one Collaboration in multi-functional and global teams Flexible work hours Attractive conditions and extensive social benefits Personal & professional development An open & international work environment in a global family-owned business Participation in the company programme "We care for your beauty"   >> Hier bewerben         Then take the next step towards the future with a top employer in the heart of Frankfurt who will offer you freedom to make your own decisions right from the start.   We look forward to receiving your online application including your salary expectation, your earliest start date, and the code 32635.     For more information, visit us at www.merz.de.    

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Vollzeit

60318 Frankfurt am Main

Frankfurt am Main