/ CAREER WITH A PURPOSE /
Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients.
Senior Manager Regulatory Affairs (w/m/d)
We are looking for support in our regulatory affairs team as soon as possible.
There is a possibilty to work remote or onsite.
Responsible and support of projects in regulatory affairs
Processing of customer inquiries and customer support
Implementation of the MDR requirements in projects
Support, give guidance and consult within regulatory requirements: MDCG, standards, guidance documents, EUDAMED, UDI, etc.
Implement technical documentation based on customer request and demand
Coordinate projects together with R&D, Marketing, Quality, Production and customer when implementing product changes and new products
Participation in product evaluations from a technical point of view and implementation of profitability analyzes based on market feedback
Responsible for product registration activities, based on customer request and demand o EU (notified body), FDA, Health Canada, NMPA, ANVISA, TGA, etc.
Management, implementation and communication with authorities (worldwide) and notified bodies
Coordinate and being responsible for authority submissions and feedback
Support in audits (ISO 13485, MDSAP, MDR)
Support within the Regulatory Affairs department on the following topics:
Post-market surveillance & post-market clinical follow-up
Drug-device combination products
Support with production problems and complaints from the market and development of proposed solutions to improve the products
Completed studies in the field of technical sciences (medical technology, engineering, industrial engineering), economics or similar
Knowledge or professional experience in the healthcare industry is desirable
Preferably with experience in regulatory affairs the field of medical devices and drug combination products
Very good English skills (written & spoken)
Very good project management skills
Very good MS-Office-skills
Willingness to travel internationally
Strong business mindset, excellent communication skills and assertiveness
Ability to work in a team and motivation
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Fresenius Kabi Deutschland GmbH
Ref. number: 49125
At a glance
Project Management, Other, Regulatory Affairs / Safety, Medical Technology
Permanent / Full-time
Bad Hersfeld / Hessen
Closing date for applications:
none – we look forward to your application
Over 300,000 people across the globe work at Fresenius to provide better medicine for more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career – and to become part of our impressive growth story.
One of Fresenius‘ strengths:
our corporate culture for „entrepreneurs in an enterprise“ where you can quickly take on responsibility.
The benefits we offer:
Profit-sharing, long-term accounts for your future plans and other benefits which meet individual needs.
> More reasons
> More benefits
Fresenius Kabi Deutschland GmbH https://files.relaxx.center/kcenter-google-postings/kc-20482/logo_google.png
Bad Hersfeld 36251