Regulatory and Government Affairs
Regulatory Affairs Manager (m/w/d)
Address: Via Crema, 8, Palazzo Pignano, Lombardia 26020, Italy
Job ID: R0159816
Regulatory and Government Affairs
Address: Via Crema, 8, Palazzo Pignano, Lombardia 26020, Italy
Job ID: R0159816
As a Clinic Manager at Fresenius Medical Care, you’ll manage the daily operations of our outpatient centers. More importantly, you’ll be the key driver in carrying out our mission: To deliver superior care that improves the quality of life of every patient, every day, setting the standard by which others in the health care industry are judged. This is accomplished by hiring, developing and inspiring a multi-disciplinary team, collaborating with physicians, tracking and delivering superior patient outcomes and monitoring regulatory and safety requirements. Strong management skills are required and prior direct patient care experience is needed for occasions when the team needs a helping hand.
Patient Care Technicians (PCTs) at Fresenius Medical Care support and collaborate with RNs to provide dialysis treatment to several patients at a time while maintaining the functionality of the clinic. This involves prepping and testing equipment, reviewing treatment sheets, and opening the clinic at 4am for first shift. PCTs have a combination of technical skills and genuine passion needed to develop deep relationships with patients and improve their quality of life. Qualified candidates have prior customer service, healthcare and direct patient care experience, and will have the opportunity to learn the discipline of dialysis.
Fresenius Medical Care nurses are on the front line of patient care, improving the quality of life of every patient, every day. That means providing dialysis care to 10-12 patients at any given time, and collaborating with our multi-disciplinary team to deliver a unique care plan to each one of them. This role is all about relationships and the bond you’ll create with patients and their families. Prior dialysis nursing experience is helpful, but many successful candidates come from a background in ICU, PCU and/or surgery.
Support product registrations, provide design input and assess changes to ensure regulatory product availability on global markets as per In-Center commercial strategy.
Tasks
Obtain and sustain global registrations for In-Center product portfolio as per Regulatory Strategy and product roadmap
Compile Global Registration File per product and customise/ supplement in preparation of local submission where necessary
Communicate / collaborate with relevant interfaces e.g., In-Center Product Centers and Value Streams, SYSQARA Regulatory Affairs and Registration Centers of Verticals Home and CC&V.
Perform site registrations
Provide regulatory design input as per available information from SYSQARA functions as well as submission strategy guidance to sustaining and development project teams in In-Center Value Streams to ensure creation of approval-relevant 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
Initiate production transfer after registration approval
Perform tasks relevant to the Quality Management System e.g., CAPA
Prepare regulatory documentation required for tender procedures
Requirements
Completed studies in a scientific/technical field or comparable training with professional experience.
Minimum 1 year of professional experience in the field of Regulatory Affairs, Quality Management or other related Research and Development functions.
Languages
English, written and oral, preferably competence level C1-2, minimum B2
German optional
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
What makes a successful member of our team? Check out the top traits we are looking for and see if you have the right mix.
“You have a lot of independence...so the doctors trust you. You have to be able to make decisions on your own.”
We fully believe that dedication and passion should be recognized and rewarded. That’s why we offer a competitive compensation and benefits package to all of our employees. Our benefits provide the flexibility, choice and support you need to be at your best as you play a vital part in helping patients live longer, better and healthier lives.
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