Regulatory Affairs Specialist - Sankt Wendel, Deutschland - Fresenius Medical Care

Fresenius Medical Care

Geprüftes Unternehmen

Sankt Wendel, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Your assignments:

Obtain and sustain global registrations for product portfolio as per Regulatory Strategy and product roadmap
Provide overarching regulatory expertise on Russia and Eurasian Economic Union for complete In-Center portfolio
Compile global registration file (STED) per product and customize/ supplement in preparation of local submission where necessary
Perform site registrations
Provide regulatory design input as per available information as well as submission strategy guidance to sustaining and development project teams to ensure creation of approvalrelevant documents
Determine and maintain relevant criteria and on that basis assess design and process changes, initiate local evaluation of potential regulatory impact as appropriate, monitor local feedback
Support global agency audits e.g., by FDA, NMPA, INMETRO and audits by Notified Body
Perform tasks relevant to the Quality Management System e.g., CAPA
Prepare regulatory documentation required for tender procedures

Your profile:

Completed studies in a scientific/technical field or comparable training with professional experience
First professional experience in the field of Regulatory Affairs, Quality Management or other related Research and Development functions
Indepth knowledge of the specific regulatory environment in Russia and Eurasian Economic Union including familiarity with applicable regulations (e.g., Judgement N1416, Orders 885n and 11n for local registration and Guidelines No.29, Decision 46, Resolution 144 for EAEU registrations)
Business proficient in Russian (written and spoken), competent use of English

Our offer to you:

There is a lot for you to discover at Fresenius, because we have a lot to offer.

No matter in which field you are an expert (M/F/d) and how much experience you bring with you - for your professional future with meaning:

The opportunity to work on a mobile basis, individually in consultation with your manager
Whether in front of or behind the scenes you will help to make better and better medicine available to more and more people around the world
Individual opportunities for selfdetermined career planning and professional development
A corporate culture in which there is enough room for innovative thinking to find the best, not the fastest, solution together
A large number of committed people with a wide range of skills, talents and experience
The benefits of a successful global corporation with the collegial culture of a mediumsized company