Regulatory Affairs Manager Medical Devices (m/f/d)

60306, Frankfurt am Main
30.07.2020

Daten dieser Anzeige

Job-ID: 015759056
Regulatory Affairs Manager Medical Devices (m/f/d)

Merz Aesthetics

Germany

https://merzpharma-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.jobinfo&jobid=1005&company_id=30120&version=1&source=ONLINE&jobOwner=992452&aid=1

For the Merz Aesthetics medical device portfolio (mainly class III devices) with focus on the Middle East & Africa and CIS region: You prepare and submit applications for new marketing authorisations/registrations and respond to questions in a timely and accurate manner You compile and update dossiers for marketing authorisations/registrations, advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide You will also assess dossiers of third parties You prepare and update product information texts according to company core data and relevant guidelines and are also responsible for the translation management You conduct scientific advice meetings with regulatory authorities and communicate with regulatory authorities worldwide You are responsible for the maintenance and Life-Cycle Management worldwide (preparation and submissions of applications for renewals, variations, submissions, annual reports etc. in due time) You coordinate change control procedures (collection of regulatory assesments worldwide) and their international implementation You organize regulatory projects, communicate with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues and manage regulatory consultants You coordinate the development of regulatory strategies, participate in project teams and act as the contact person with regards to regulatory requirements You maintain the regulatory data bases You conduct Due Diligences with regards to regulatory aspects

  ABOUT US: 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       Regulatory Affairs Manager Medical Devices (m/f/d)  Medical Devices ROW limited for 12 months      THE FOLLOWING RESPONSIBILITIES ARE AWAITING YOU:   For the Merz Aesthetics medical device portfolio (mainly class III devices) with focus on the Middle East & Africa and CIS region:   You prepare and submit applications for new marketing authorisations/registrations and respond to questions in a timely and accurate manner You compile and update dossiers for marketing authorisations/registrations, advice to concerned development departments regarding the quality, analytical methods, pre-clinical and clinical development to ensure acceptance of the data worldwide You will also assess dossiers of third parties You prepare and update product information texts according to company core data and relevant guidelines and are also responsible for the translation management You conduct scientific advice meetings with regulatory authorities and communicate with regulatory authorities worldwide You are responsible for the maintenance and Life-Cycle Management worldwide (preparation and submissions of applications for renewals, variations, submissions, annual reports etc. in due time) You coordinate change control procedures (collection of regulatory assesments worldwide) and their international implementation You organize regulatory projects, communicate with third parties (e.g. consultants, CROs, distribution partner) concerning regulatory issues and manage regulatory consultants You coordinate the development of regulatory strategies, participate in project teams and act as the contact person with regards to regulatory requirements You maintain the regulatory data bases You conduct Due Diligences with regards to regulatory aspects     WHAT WE EXPECT FROM YOU:    Natural scientific or medical device engineering background (pharmacist, biologist, chemist etc.) with approbation, diploma, master degree or PhD 3-6 years of experience in international regulatory affairs field for medical devices Business fluent in English, further foreign languages, especially Arabic and/or Eastern European languages preferred Networking abilities with internal and external stakeholders (health authorities) Strategic and analytical thinking Highly Structured way of working Comprehensive knowledge of processes and regulations in medical device and drug development   Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point, Outlook)  Excellent communicating and networking skills Goal- and solution orientation, flexibility and assertiveness       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"   YOUR APPLICATION:>> 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 26805.     For more information, visit us at www.merz.de.    

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Medizinische Tätigkeiten/ Gesundheits-/ Sozialwesen

Chemie/ Pharma/ Biotechnologie

Angestellter/ Fachkraft

Teilzeit

Befristet

60306

Frankfurt am Main